## Protocol Section
### Identification Module
**NCT ID:** NCT01735279

**Brief Title:** Studying the Effects of Administration of Polyunsaturated Fatty Acids (PUFAS) of Omega-3 Series in Nicotine Dependence

**Official Title:** "Studying the Effects of Administration of Polyunsaturated Fatty Acids (PUFAS) of Omega-3 Series in Nicotine Dependence"

#### Organization Study ID Info
**ID:** Tobacco&Omega
#### Organization
**Class:** OTHER
**Full Name:** Federal University of São Paulo
### Status Module
#### Completion Date
**Date:** 2014-03

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-10-14

**Type:** ACTUAL

**Last Update Submit Date:** 2020-09-18

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2013-12

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2020-10-14

**Type:** ACTUAL

**Results First Submit Date:** 2016-01-06

**Results First Submit QC Date:** 2020-09-18

#### Start Date
**Date:** 2013-01

**Type:** ACTUAL

**Status Verified Date:** 2020-09

#### Study First Post Date
**Date:** 2012-11-28
**Type:** ESTIMATED
**Study First Submit Date:** 2012-11-23
**Study First Submit QC Date:** 2012-11-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Federal University of São Paulo

#### Responsible Party

**Investigator Affiliation:** Federal University of São Paulo

**Investigator Full Name:** Jose Carlos Fernandes Galduroz MD

**Investigator Title:** Md PhD

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Nicotine dependence may prolong the exposure to toxic substances that cause various diseases. The Central Nervous System (CNS) is consisted by a large amount of Polyunsaturated Fatty Acids (PUFAS) from omega-3 serie. Omega-3 takes part in several actions, including the modulation of dopaminergic neurotransmission. In its deficiency is detected a hypofunctioning of the mesolimbic and mesocortical pathway, related to the reward system, involved on the context of nicotine dependence. Treatment using dietary supplementation with omega-3 shows improvements in several diseases, including mood disorders such as anxiety and depression. The investigators hypothesis is that supplementation with these fatty acids can restore the levels of omega-3 and could decrease nicotine dependence. The investigators objective is to investigate a possible association between increased serum levels of omega-3 and the reduction in nicotine dependence.

**Detailed Description:** Introduction: A cigarette has more than 6,000 toxic substances that can cause various diseases. Nicotine dependence may prolong the exposure to these toxic substances. The Central Nervous System (CNS) is consisted by a large amount of Polyunsaturated Fatty Acids (PUFAS) from omega-3 serie. Omega-3 takes part in several actions, including the modulation of dopaminergic neurotransmission. In its deficiency is detected a hypofunctioning of the mesolimbic and mesocortical pathway, related to the reward system, involved on the context of nicotine dependence. Treatment using dietary supplementation with omega-3 shows improvements in several diseases, including mood disorders such as anxiety and depression. The investigators hypothesis is that supplementation with these fatty acids can restore the levels of omega-3 and could decrease nicotine dependence. Objective: Investigate a possible association between increased serum levels of omega-3 and the reduction in nicotine dependence. Material and Methods: In the clinical study, placebo controlled, double-blind, parallel, randomized, will be administered to 60 volunteers: placebo or fish oil for 90 days. Psychometric assessments will be carried out, measurements of serum levels of PUFAS, levels of carbon monoxide (CO) and cotinine in plasma will be done for monitoring the clinical course. Data Analysis: Repeated measures (ANOVA) for the dependent variables (dependency, anxiety, depression, motivation, compulsion, dosage of PUFAS, exhaled CO and cotinine) and independent (groups and time) to check for significant differences. If so, a second ANOVA with covariates will be conducted. Significance is p \<0.05 in all analyzes.

### Conditions Module

**Conditions:**

- Tobacco Dependence

- Nicotine Dependence

**Keywords:**

- tobacco dependence

- tobacco treatment

- omega 3 series

- polyunsaturated fatty acids

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 58

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The placebo group will receive 3g per day of mineral oil during 90 days treatment

**Intervention Names:**

- Drug: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

#### Arm Group 2

**Description:** The omega 3 group will receive 3g per day of fish oil during 90 days treatment

**Intervention Names:**

- Drug: Omega 3

**Label:** Omega3

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Omega3

**Description:** Each fish oil capsule contained 210.99 mg of EPA and 129.84 mg of DHA.

**Name:** Omega 3

**Other Names:**

- fish oil

- omega 3 fatty acid

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** mineral oil + food dye #2 (simulating the colour of essential fatty acids); 1000 mg of mineral oil per capsule

**Name:** Placebo

**Other Names:**

- mineral oil

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** The Fageström Test for Nicotine Dependence is a widely used test to measure the nicotine dependence. This test was chosen to evaluate the possible changes on the nicotine dependence during the clinical trial.

The range for the scale is:

very low (dependence) 0-2 low (dependence) 3-4 moderate (dependence) 5 high (dependence) 6-7 very high (dependence) 8-10

So, lower levels (low scores on the scale) of the FTND measure indicates lower nicotine dependence, and higher levels (high scores on the scales) of the FTND measure indicates higher nicotine dependence.

**Measure:** Fageström Test for Nicotine Dependence Score at Baseline and After 90 Days of the Treatment

**Time Frame:** Baseline (prior to the beginning) and after 90 days of the treatment

#### Secondary Outcomes

**Description:** The polyunsaturated fatty acid Docosahexaenoic acid (DHA) is one of the main fatty acids omega-3 series. The dosage of these analyte was achieved by means of Liquid Chromatography - Mass Spectrometry Mass Spectrometry - LS-MS-MS.

**Measure:** Concentration of Docosahexaenoic Acid (DHA) at Baseline and After 90 Days of Treatment

**Time Frame:** At baseline (prior to the beginning of the treatment) and after 90 days of treatment

**Description:** The polyunsaturated fatty acid Eicosapentaenoic acid (EPA) is one of the main fatty acids omega-3 series. The dosage of these analyte was achieved by means of Liquid Chromatography - Mass Spectrometry Mass Spectrometry - LS-MS-MS.

**Measure:** Concentration of Eicosapentaenoic Acid (EPA)

**Time Frame:** At baseline (prior to the beginning of the treatment) and after 90 days of treatment

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* healthy smokers; age between 20 and 60 years; score in Fagerström Test for Nicotine Dependence (FTND) up to 5 points (FTND \> 5); high motivation to stop smoking (accessed by Richmond Test)

Exclusion Criteria:

* psychiatric disorders; taking psychoactive medications; history of alcohol and/or other drugs abuse or dependence;

**Healthy Volunteers:** True

**Maximum Age:** 60 Years

**Minimum Age:** 20 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** São Paulo

**Country:** Brazil

**Facility:** Unidade de Dependência de Drogas (UDED)

**Zip:** 55

#### Overall Officials

**Official 1:**

**Affiliation:** Universidade Federal de São Paulo (UNIFESP)

**Name:** José Carlos F. Galduróz, Md PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** We do not plan to make individual participant data available. The data obtained was analysed and published

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000019966

- Term: Substance-Related Disorders

- ID: D000064419

- Term: Chemically-Induced Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC25

- Name: Substance Related Disorders

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M16785

- Name: Tobacco Use Disorder

- Relevance: HIGH

- As Found: Nicotine Dependence

- ID: M21837

- Name: Substance-Related Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M30302

- Name: Chemically-Induced Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000014029

- Term: Tobacco Use Disorder

### Intervention Browse Module - Ancestors

- ID: D000004643

- Term: Emollients

- ID: D000003879

- Term: Dermatologic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Derm

- Name: Dermatologic Agents

- Abbrev: Ot

- Name: Other Dietary Supplements

### Intervention Browse Module - Browse Leaves

- ID: M12478

- Name: Nicotine

- Relevance: LOW

- As Found: Unknown

- ID: M11869

- Name: Mineral Oil

- Relevance: HIGH

- As Found: Hypoparathyroidism

- ID: M7809

- Name: Emollients

- Relevance: LOW

- As Found: Unknown

- ID: M7074

- Name: Dermatologic Agents

- Relevance: LOW

- As Found: Unknown

- ID: T415

- Name: Omega 3 Fatty Acid

- Relevance: HIGH

- As Found: Machine

### Intervention Browse Module - Meshes

- ID: D000008899

- Term: Mineral Oil

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** No adverse event were reported by the participants

#### Event Groups

**Group ID:** EG000

**Title:** Placebo Group n= 29

**Deaths Num At Risk:** 29

**Description:** placebo capsules 1,000 mg - mineral oil + food dye #2 (simulating the colour of essential fatty acids), taken in 3 daily doses, for 90 days.

**ID:** EG000

**Other Num at Risk:** 29

**Serious Number At Risk:** 29

**Title:** Placebo Group n= 29

**Group ID:** EG001

**Title:** Omega3 Group n= 29

**Deaths Num At Risk:** 29

**Description:** omega 3 capsules 1,000 mg fish oil taken as 3 daily doses, for 90 days. Each fish oil capsule contained 210.99 mg of EPA and 129.84 mg of DHA

**ID:** EG001

**Other Num at Risk:** 29

**Serious Number At Risk:** 29

**Title:** Omega3 Group n= 29

**Frequency Threshold:** 5

**Time Frame:** The adverse event were collected monthly (after 30, 60 and 90 days of the treatment) during the 90 days (treatment time)

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 29

**Group ID:** BG001

**Value:** 29

**Group ID:** BG002

**Value:** 58

**Units:** Participants

### Group

**ID:** BG000

**Title:** Placebo

**Description:** placebo capsules 1,000 mg - mineral oil + food dye #2 (simulating the colour of essential fatty acids), taken in 3 daily doses, for 90 days.

### Group

**ID:** BG001

**Title:** Omega3

**Description:** omega 3 capsules 1,000 mg fish oil taken as 3 daily doses, for 90 days. Each fish oil capsule contained 210.99 mg of EPA and 129.84 mg of DHA

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 11.5

**Value:** 47.8

#### Measurement

**Group ID:** BG001

**Spread:** 11.1

**Value:** 46.2

#### Measurement

**Group ID:** BG002

**Spread:** 11.3

**Value:** 47

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 15

#### Measurement

**Group ID:** BG001

**Value:** 13

#### Measurement

**Group ID:** BG002

**Value:** 28

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 14

#### Measurement

**Group ID:** BG001

**Value:** 16

#### Measurement

**Group ID:** BG002

**Value:** 30

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 4.7

**Value:** 24.3

#### Measurement

**Group ID:** BG001

**Spread:** 3.9

**Value:** 24.7

#### Measurement

**Group ID:** BG002

**Spread:** 4.3

**Value:** 24.5

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Body Mass Index (BMI)
**Unit of Measure:** kg/m^2
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** galduroz@unifesp.br
**Organization:** Department of Psychobiology, Universidade Federal de São Paulo (UNIFESP), Rua Napoleão de Barros, São Paulo , Brazil
**Phone:** +55 11 2149 0000
**Title:** Md PhD José Carlos F. Galduróz
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** Test t Student
**Non-Inferiority Type:** OTHER
**Other Analysis Description:** 
**P-Value:** <0.05
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 0.05
**Statistical Comment:** 
**Statistical Method:** ANOVA
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** ONE_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** <0.01
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 30.84
**Statistical Comment:** 
**Statistical Method:** ANOVA
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** <0.01
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 0.002
**Statistical Comment:** 
**Statistical Method:** t-test, 1 sided
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** ONE_SIDED
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** <0.01
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 4.4
**Statistical Comment:** 
**Statistical Method:** t-test, 1 sided
**Tested Non-Inferiority:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.01
- **Upper Limit:** 
- **Value:** 6.53
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.52
- **Upper Limit:** 
- **Value:** 6.56
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.85
- **Upper Limit:** 
- **Value:** 5.96
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.15
- **Upper Limit:** 
- **Value:** 5.22
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 794.00
- **Upper Limit:** 
- **Value:** 747.71
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 757.49
- **Upper Limit:** 
- **Value:** 645.38
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 767.41
- **Upper Limit:** 
- **Value:** 663.93
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1,484.63
- **Upper Limit:** 
- **Value:** 1,004.94
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 67.72
- **Upper Limit:** 
- **Value:** 77.00
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 111.79
- **Upper Limit:** 
- **Value:** 86.76
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 73.22
- **Upper Limit:** 
- **Value:** 77.39
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 285.37
- **Upper Limit:** 
- **Value:** 174.87
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 65.10
- **Upper Limit:** 
- **Value:** 101.20
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 85.15
- **Upper Limit:** 
- **Value:** 129.38
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 63.26
- **Upper Limit:** 
- **Value:** 97.79
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 61.94
- **Upper Limit:** 
- **Value:** 98.54
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** The Fageström Test for Nicotine Dependence is a widely used test to measure the nicotine dependence. This test was chosen to evaluate the possible changes on the nicotine dependence during the clinical trial.

The range for the scale is:

very low (dependence) 0-2 low (dependence) 3-4 moderate (dependence) 5 high (dependence) 6-7 very high (dependence) 8-10

So, lower levels (low scores on the scale) of the FTND measure indicates lower nicotine dependence, and higher levels (high scores on the scales) of the FTND measure indicates higher nicotine dependence.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Baseline (prior to the beginning) and after 90 days of the treatment
**Title:** Fageström Test for Nicotine Dependence Score at Baseline and After 90 Days of the Treatment
**Type:** PRIMARY
**Unit of Measure:** units on a scale
##### Group
**Description:** placebo capsules 1,000 mg - mineral oil + food dye #2 (simulating the colour of essential fatty acids), taken in 3 daily doses, for 90 days.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** omega 3 capsules 1,000 mg fish oil taken as 3 daily doses, for 90 days. Each fish oil capsule contained 210.99 mg of EPA and 129.84 mg of DHA
**ID:** OG001
**Title:** Omega3
#### Outcome Measure 2
**Description:** The polyunsaturated fatty acid Docosahexaenoic acid (DHA) is one of the main fatty acids omega-3 series. The dosage of these analyte was achieved by means of Liquid Chromatography - Mass Spectrometry Mass Spectrometry - LS-MS-MS.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** At baseline (prior to the beginning of the treatment) and after 90 days of treatment
**Title:** Concentration of Docosahexaenoic Acid (DHA) at Baseline and After 90 Days of Treatment
**Type:** SECONDARY
**Unit of Measure:** ng/ml
##### Group
**Description:** placebo capsules 1,000 mg - mineral oil + food dye #2 (simulating the colour of essential fatty acids), taken in 3 daily doses, for 90 days.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** omega 3 capsules 1,000 mg fish oil taken as 3 daily doses, for 90 days. Each fish oil capsule contained 210.99 mg of EPA and 129.84 mg of DHA
**ID:** OG001
**Title:** Omega3
#### Outcome Measure 3
**Description:** The polyunsaturated fatty acid Eicosapentaenoic acid (EPA) is one of the main fatty acids omega-3 series. The dosage of these analyte was achieved by means of Liquid Chromatography - Mass Spectrometry Mass Spectrometry - LS-MS-MS.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** At baseline (prior to the beginning of the treatment) and after 90 days of treatment
**Title:** Concentration of Eicosapentaenoic Acid (EPA)
**Type:** SECONDARY
**Unit of Measure:** ng/ml
##### Group
**Description:** placebo capsules 1,000 mg - mineral oil + food dye #2 (simulating the colour of essential fatty acids), taken in 3 daily doses, for 90 days.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** omega 3 capsules 1,000 mg fish oil taken as 3 daily doses, for 90 days. Each fish oil capsule contained 210.99 mg of EPA and 129.84 mg of DHA
**ID:** OG001
**Title:** Omega3
#### Outcome Measure 4
**Description:** Cotinine is the major metabolite of nicotine, making it its primary metabolite. Cotinine dosage is considered one of the best parameters to distinguish smokers from non-smokers as well as for the nicotine graduation consumption. The traditional cut off value used to distinguish between smokers and non-smokers is 15 ng/mL for dosages from plasma sample
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** At baseline (prior to the beginning of the treatment) and after 90 days of treatment
**Title:** Concentration of Serum Cotinine at Baseline and After 90 Days of Treatment
**Type:** POST_HOC
**Unit of Measure:** ng/ml
##### Group
**Description:** placebo capsules 1,000 mg - mineral oil + food dye #2 (simulating the colour of essential fatty acids), taken in 3 daily doses, for 90 days.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** omega 3 capsules 1,000 mg fish oil taken as 3 daily doses, for 90 days. Each fish oil capsule contained 210.99 mg of EPA and 129.84 mg of DHA
**ID:** OG001
**Title:** Omega3
### Participant Flow Module
#### Group
**Description:** placebo capsules 1,000 mg - mineral oil + food dye #2 (simulating the colour of essential fatty acids), taken in 3 daily doses.
**ID:** FG000
**Title:** Placebo
#### Group
**Description:** omega 3 capsules 1,000 mg fish oil taken as 3 daily doses. Each fish oil capsule contained 210.99 mg of EPA and 129.84 mg of DHA
**ID:** FG001
**Title:** Omega3
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 11
###### Reason
**Group ID:** FG001
**Number of Subjects:** 8
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 29
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 29
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 18
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 21
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 11
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 8
**Pre-Assignment Details:** No participants were excluded.
**Recruitment Details:** Data were collected in São Paulo/Brazil between January 2013 and August 2013. All participants signed an informed consent prior to the beginning of the study. The participants did not receive any kind of compensation for participation in the study.
**Has Results:** True