## Protocol Section
### Identification Module
**NCT ID:** NCT00886379

**Acronym:** BSS

**Brief Title:** Blue Sky Study: Impact of Milk and Vitamin D for Child Growth and Health

**Official Title:** Blue Sky Study: Impact of Milk and Vitamin D for Child Growth and Health

#### Organization Study ID Info
**ID:** BSS-103306
#### Organization
**Class:** OTHER
**Full Name:** Brigham and Women's Hospital
### Status Module
#### Completion Date
**Date:** 2009-03

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-03-23

**Type:** ACTUAL

**Last Update Submit Date:** 2021-02-26

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2009-03

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2021-03-23

**Type:** ACTUAL

**Results First Submit Date:** 2019-05-28

**Results First Submit QC Date:** 2021-02-26

#### Start Date
**Date:** 2009-01

**Status Verified Date:** 2021-02

#### Study First Post Date
**Date:** 2009-04-22
**Type:** ESTIMATED
**Study First Submit Date:** 2009-04-20
**Study First Submit QC Date:** 2009-04-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Brigham and Women's Hospital

#### Responsible Party

**Investigator Affiliation:** Brigham and Women's Hospital

**Investigator Full Name:** Janet Rich-Edwards

**Investigator Title:** Direct of Developmental Epidemiology

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This intervention study will address the impact of vitamin D fortified milk and vitamin D supplements on the growth, levels of vitamin D, insulin-like growth factor 1, growth hormone, academic attention, respiratory infections, asthma, and flexural dermatitis (a proxy for eczema) of Mongolian children.

### Conditions Module

**Conditions:**

- Vitamin d Deficiency

**Keywords:**

- vitamin d

- children

- Mongolia

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 597

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Mongolian milk without D

**Intervention Names:**

- Dietary Supplement: Mongolian milk without vitamin D

**Label:** 1

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Mongolian milk with vitamin D

**Intervention Names:**

- Dietary Supplement: Mongolian milk with vitamin D

**Label:** 2

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Ultra High Temperature (UHT) milk

**Intervention Names:**

- Dietary Supplement: UHT milk

**Label:** 3

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** Milk Substitute

**Intervention Names:**

- Dietary Supplement: Milk Substitute

**Label:** 4

**Type:** EXPERIMENTAL

#### Arm Group 5

**Description:** Seasonal D

**Intervention Names:**

- Dietary Supplement: Seasonal D supplement

**Label:** 5

**Type:** EXPERIMENTAL

#### Arm Group 6

**Description:** Daily D

**Intervention Names:**

- Dietary Supplement: Daily D supplement

**Label:** 6

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 1

**Description:** 710ml per day for 49 days

**Name:** Mongolian milk without vitamin D

**Other Names:**

- Guum milk

**Type:** DIETARY_SUPPLEMENT

#### Intervention 2

**Arm Group Labels:**

- 2

**Description:** 710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.

**Name:** Mongolian milk with vitamin D

**Other Names:**

- Guum milk

**Type:** DIETARY_SUPPLEMENT

#### Intervention 3

**Arm Group Labels:**

- 3

**Description:** 710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.

**Name:** UHT milk

**Other Names:**

- Gossner milk

**Type:** DIETARY_SUPPLEMENT

#### Intervention 4

**Arm Group Labels:**

- 4

**Description:** 710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.

**Name:** Milk Substitute

**Other Names:**

- Mead Johnson

**Type:** DIETARY_SUPPLEMENT

#### Intervention 5

**Arm Group Labels:**

- 5

**Description:** Deliver dosage of 13,700 IU vitamin D over 7 days

**Name:** Seasonal D supplement

**Other Names:**

- Tish Con

**Type:** DIETARY_SUPPLEMENT

#### Intervention 6

**Arm Group Labels:**

- 6

**Description:** Deliver dosage of 13,700 IU vitamin D in vitamin capsules over 49 days.

**Name:** Daily D supplement

**Other Names:**

- Tish Con

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Primary Outcomes

**Description:** Baseline and Follow-up 25(OH)D3 by liquid chromatography-tandem mass spectrometry

**Measure:** Serum 25-hydroxyvitamin D Concentrations in Schoolchildren

**Time Frame:** Blood was analyzed at day 0 and day 49

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Children in 3rd and 4th grade from selected Mongolian schools.
* School selection will consider:

  * socioeconomic position;
  * geographic location;
  * school size;
  * current lunch or supplementation program; and
  * the interest and willingness to participate of the school's administration and faculty.

Exclusion Criteria:

* Allergy to milk or wheat products.

**Healthy Volunteers:** True

**Maximum Age:** 11 Years

**Minimum Age:** 9 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** Brigham and Women's Hospital

**Name:** Janet Rich-Edwards, Sc.D.

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Rich-Edwards JW, Ganmaa D, Pollak MN, Nakamoto EK, Kleinman K, Tserendolgor U, Willett WC, Frazier AL. Milk consumption and the prepubertal somatotropic axis. Nutr J. 2007 Sep 27;6:28. doi: 10.1186/1475-2891-6-28.

**PMID:** 17900364

**Citation:** Rich-Edwards JW, Ganmaa D, Kleinman K, Sumberzul N, Holick MF, Lkhagvasuren T, Dulguun B, Burke A, Frazier AL. Randomized trial of fortified milk and supplements to raise 25-hydroxyvitamin D concentrations in schoolchildren in Mongolia. Am J Clin Nutr. 2011 Aug;94(2):578-84. doi: 10.3945/ajcn.110.008771. Epub 2011 Jun 22.

**PMID:** 21697075

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001361

- Term: Avitaminosis

- ID: D000003677

- Term: Deficiency Diseases

- ID: D000044342

- Term: Malnutrition

- ID: D000009748

- Term: Nutrition Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M17551

- Name: Vitamin D Deficiency

- Relevance: HIGH

- As Found: Vitamin D Deficiency

- ID: M4660

- Name: Avitaminosis

- Relevance: LOW

- As Found: Unknown

- ID: M6879

- Name: Deficiency Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25306

- Name: Malnutrition

- Relevance: LOW

- As Found: Unknown

- ID: M12684

- Name: Nutrition Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000014808

- Term: Vitamin D Deficiency

### Intervention Browse Module - Ancestors

- ID: D000018977

- Term: Micronutrients

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000050071

- Term: Bone Density Conservation Agents

- ID: D000077264

- Term: Calcium-Regulating Hormones and Agents

### Intervention Browse Module - Browse Branches

- Abbrev: BDCA

- Name: Bone Density Conservation Agents

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Vi

- Name: Vitamins

### Intervention Browse Module - Browse Leaves

- ID: M17550

- Name: Vitamin D

- Relevance: HIGH

- As Found: Ultrasound

- ID: M6003

- Name: Cholecalciferol

- Relevance: HIGH

- As Found: Ultrasound

- ID: M17558

- Name: Vitamins

- Relevance: HIGH

- As Found: Every

- ID: M8026

- Name: Ergocalciferols

- Relevance: HIGH

- As Found: Ultrasound

- ID: M21009

- Name: Micronutrients

- Relevance: LOW

- As Found: Unknown

- ID: M16885

- Name: Trace Elements

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M5381

- Name: Calcium

- Relevance: LOW

- As Found: Unknown

- ID: M5398

- Name: Calcium, Dietary

- Relevance: LOW

- As Found: Unknown

- ID: T442

- Name: Cholecalciferol

- Relevance: HIGH

- As Found: Ultrasound

- ID: T479

- Name: Vitamin D3

- Relevance: HIGH

- As Found: Ultrasound

- ID: T440

- Name: Calciferol

- Relevance: HIGH

- As Found: Ultrasound

- ID: T445

- Name: Ergocalciferol

- Relevance: HIGH

- As Found: Ultrasound

- ID: T478

- Name: Vitamin D2

- Relevance: HIGH

- As Found: Ultrasound

### Intervention Browse Module - Meshes

- ID: D000014807

- Term: Vitamin D

- ID: D000004872

- Term: Ergocalciferols

- ID: D000002762

- Term: Cholecalciferol

- ID: D000014815

- Term: Vitamins

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Unfortified Mongolain Milk

**Deaths Num At Risk:** 101

**Description:** Mongolian milk without vitamin D: 710ml per day for 49 days

**ID:** EG000

**Other Num at Risk:** 101

**Serious Number At Risk:** 101

**Title:** Unfortified Mongolain Milk

**Group ID:** EG001

**Title:** Fortified Mongolian Milk

**Deaths Num At Risk:** 140

**Description:** Mongolian milk with vitamin D: 710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.

**ID:** EG001

**Other Num at Risk:** 140

**Serious Number At Risk:** 140

**Title:** Fortified Mongolian Milk

**Group ID:** EG002

**Title:** Fortified UHT Milk

**Deaths Num At Risk:** 137

**Description:** UHT milk: 710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.

**ID:** EG002

**Other Num at Risk:** 137

**Serious Number At Risk:** 137

**Title:** Fortified UHT Milk

**Group ID:** EG003

**Title:** Daily Vitamin D Supplements

**Deaths Num At Risk:** 109

**Description:** Daily D supplement: Deliver dosage of 13,700 IU vitamin D in vitamin capsules over 49 days.

**ID:** EG003

**Other Num at Risk:** 109

**Serious Number At Risk:** 109

**Title:** Daily Vitamin D Supplements

**Group ID:** EG004

**Title:** Seasonal Vitamin D Supplements

**Deaths Num At Risk:** 92

**Description:** Seasonal D supplement: Deliver dosage of 13,700 IU vitamin D over 7 days

**ID:** EG004

**Other Num at Risk:** 92

**Serious Number At Risk:** 92

**Title:** Seasonal Vitamin D Supplements

**Frequency Threshold:** 0

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 101

**Group ID:** BG001

**Value:** 140

**Group ID:** BG002

**Value:** 137

**Group ID:** BG003

**Value:** 109

**Group ID:** BG004

**Value:** 92

**Group ID:** BG005

**Value:** 579

**Units:** Participants

### Group

**ID:** BG000

**Title:** Unfortified Mongolain Milk

**Description:** Mongolian milk without vitamin D: 710ml per day for 49 days

### Group

**ID:** BG001

**Title:** Fortified Mongolian Milk

**Description:** Mongolian milk with vitamin D: 710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.

### Group

**ID:** BG002

**Title:** Fortified UHT Milk

**Description:** UHT milk: 710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.

### Group

**ID:** BG003

**Title:** Daily Vitamin D Supplements

**Description:** Daily D supplement: Deliver dosage of 13,700 IU vitamin D in vitamin capsules over 49 days.

### Group

**ID:** BG004

**Title:** Seasonal Vitamin D Supplements

**Description:** Seasonal D supplement: Deliver dosage of 13,700 IU vitamin D over 7 days

### Group

**ID:** BG005

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 101

#### Measurement

**Group ID:** BG001

**Value:** 140

#### Measurement

**Group ID:** BG002

**Value:** 137

#### Measurement

**Group ID:** BG003

**Value:** 109

#### Measurement

**Group ID:** BG004

**Value:** 92

#### Measurement

**Group ID:** BG005

**Value:** 579

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 0

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 0

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 51

#### Measurement

**Group ID:** BG001

**Value:** 65

#### Measurement

**Group ID:** BG002

**Value:** 69

#### Measurement

**Group ID:** BG003

**Value:** 45

#### Measurement

**Group ID:** BG004

**Value:** 41

#### Measurement

**Group ID:** BG005

**Value:** 271

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 50

#### Measurement

**Group ID:** BG001

**Value:** 75

#### Measurement

**Group ID:** BG002

**Value:** 68

#### Measurement

**Group ID:** BG003

**Value:** 64

#### Measurement

**Group ID:** BG004

**Value:** 51

#### Measurement

**Group ID:** BG005

**Value:** 308

**Category Title:** Male

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Point of Contact
**Email:** jr33@partners.org
**Organization:** Brigham and Women's Hospital
**Phone:** 617-525-7929
**Title:** Dr. Janet Rich-Edwards
## Results Section - Outcome Measures Module
### Outcome Measure 1
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 4
- **Upper Limit:** 
- **Value:** 8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 4
- **Upper Limit:** 
- **Value:** 8
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 5
- **Upper Limit:** 
- **Value:** 10
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 3
- **Upper Limit:** 
- **Value:** 7
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 4
- **Upper Limit:** 
- **Value:** 8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 4
- **Upper Limit:** 
- **Value:** 8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 6
- **Upper Limit:** 
- **Value:** 20
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 10
- **Upper Limit:** 
- **Value:** 29
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 6
- **Upper Limit:** 
- **Value:** 21
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 4
- **Upper Limit:** 
- **Value:** 12
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Baseline and Follow-up 25(OH)D3 by liquid chromatography-tandem mass spectrometry
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Blood was analyzed at day 0 and day 49
**Title:** Serum 25-hydroxyvitamin D Concentrations in Schoolchildren
**Type:** PRIMARY
**Unit of Measure:** ng/ml
##### Group
**Description:** Mongolian milk without vitamin D: 710ml per day for 49 days
**ID:** OG000
**Title:** Unfortified Mongolain Milk
##### Group
**Description:** Mongolian milk with vitamin D: 710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.
**ID:** OG001
**Title:** Fortified Mongolian Milk
##### Group
**Description:** UHT milk: 710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.
**ID:** OG002
**Title:** Fortified UHT Milk
##### Group
**Description:** Daily D supplement: Deliver dosage of 13,700 IU vitamin D in vitamin capsules over 49 days.
**ID:** OG003
**Title:** Daily Vitamin D Supplements
##### Group
**Description:** Seasonal D supplement: Deliver dosage of 13,700 IU vitamin D over 7 days
**ID:** OG004
**Title:** Seasonal Vitamin D Supplements
### Participant Flow Module
#### Group
**Description:** Mongolian milk without vitamin D: 710ml per day for 49 days
**ID:** FG000
**Title:** Unfortified Mongolian Milk
#### Group
**Description:** Mongolian milk with vitamin D: 710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.
**ID:** FG001
**Title:** Fortified Mongolian Milk
#### Group
**Description:** UHT milk: 710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.
**ID:** FG002
**Title:** Fortified UHT Milk
#### Group
**Description:** Daily D supplement: Deliver dosage of 13,700 IU vitamin D in vitamin capsules over 49 days.
**ID:** FG003
**Title:** Daily Vitamin D Supplements
#### Group
**Description:** Seasonal D supplement: Deliver dosage of 13,700 IU vitamin D over 7 days
**ID:** FG004
**Title:** Seasonal Vitamin D Supplements
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Transferred Schools
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 2
###### Reason
**Group ID:** FG003
**Number of Subjects:** 1
###### Reason
**Group ID:** FG004
**Number of Subjects:** 1
##### Withdraw
**Type:** Final blood draw not obtained
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
###### Reason
**Group ID:** FG001
**Number of Subjects:** 3
###### Reason
**Group ID:** FG002
**Number of Subjects:** 4
###### Reason
**Group ID:** FG003
**Number of Subjects:** 2
###### Reason
**Group ID:** FG004
**Number of Subjects:** 2
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 104
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 143
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 143
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 112
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 95
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 101
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 140
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 137
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 109
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 92
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 6
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 3
**Has Results:** True