## Protocol Section
### Identification Module
**NCT ID:** NCT01102179

**Brief Title:** Vitamin D Insufficiency and Deficiency in Chronic Kidney Disease (CKD) Patients in Singapore

**Official Title:** Prevalence of Vitamin D Insufficiency and Deficiency in Chronic Kidney Disease Patients in Singapore

#### Organization Study ID Info
**ID:** DSRB Domain E/09/643
#### Organization
**Class:** OTHER
**Full Name:** National University of Singapore
### Status Module
#### Completion Date
**Date:** 2014-07

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2014-11-07

**Type:** ESTIMATED

**Last Update Submit Date:** 2014-11-06

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2014-07

**Type:** ACTUAL

#### Start Date
**Date:** 2010-04

**Status Verified Date:** 2014-10

#### Study First Post Date
**Date:** 2010-04-13
**Type:** ESTIMATED
**Study First Submit Date:** 2010-04-12
**Study First Submit QC Date:** 2010-04-12
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** National Kidney Foundation, Singapore

#### Lead Sponsor

**Class:** OTHER

**Name:** National University of Singapore

#### Responsible Party

**Old Name Title:** Dr. Priscilla How

**Old Organization:** National University Singapore/National University Hospital

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Vitamin D insufficiency and deficiency is common in chronic kidney disease (CKD) patients and is associated with elevated parathyroid hormone (PTH) concentration and mineral and bone disorder (MBD). There is also increasing evidence to show that these abnormalities increase cardiovascular morbidity and mortality in CKD patients. There is a need for early identification of vitamin D insufficiency/deficiency in CKD patients to prevent its long-term complications. However, the vitamin D status of CKD patients in Singapore has not been well described. The purpose of this study is to assess the vitamin D status of predialysis CKD patients in a tertiary academic teaching hospital in Singapore, and its association with parameters for MBD. Predialysis patients from the outpatient renal clinic at the National University Hospital (NUH) will be recruited into this study. Blood samples from the patients will be collected after an overnight fast to determine their serum 25(OH)D, creatinine, phosphorus, calcium, albumin and i-PTH concentrations. These parameters will be compared among patients in various stages of CKD.

### Conditions Module

**Conditions:**

- Stage 2-5 Chronic Kidney Disease

- Predialysis

### Design Module

#### Design Info

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 196

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** All patients with stage 2-5 (pre-dialysis) chronic kidney disease

One-time blood draw (10 ml)

**Label:** Chronic kidney disease

### Outcomes Module

#### Primary Outcomes

**Description:** Vitamin D levels are only measured at one time point i.e. at baseline

**Measure:** Vitamin D 25(OH)D levels

**Time Frame:** baseline

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Male or female 21 years of age or older
* CKD stage 2 to 5 (who are not on dialysis): CKD stage 2: eGFR 60-89ml/min/1.73m2, stage 3: eGFR 30-59ml/min/1.73m2, stage 4: eGFR 15-29 ml/min/1.73m2, stage 5 eGFR \<15 ml/min/1.73m2)
* Not receiving over-the-counter or prescription vitamin D therapy
* On a stable dose of phosphate binder (if any) for at least 1 month prior to the study

Exclusion Criteria:

* History of liver and chronic inflammatory diseases, primary hyperparathyroidism and malignancies
* Use of corticosteroids, anticonvulsants or vitamin D compounds
* Use of an investigational agent within 30 days of study entry

**Minimum Age:** 21 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients with stage 2-5 chronic kidney disease who are not on dialysis

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Singapore

**Country:** Singapore

**Facility:** National University Hospital

#### Overall Officials

**Official 1:**

**Affiliation:** National University of Singapore/National University Hospital

**Name:** Priscilla P How, Pharm.D.

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

- ID: D000051437

- Term: Renal Insufficiency

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10698

- Name: Kidney Diseases

- Relevance: HIGH

- As Found: Kidney Disease

- ID: M26717

- Name: Renal Insufficiency, Chronic

- Relevance: HIGH

- As Found: Chronic Kidney Disease

- ID: M26718

- Name: Renal Insufficiency

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007674

- Term: Kidney Diseases

- ID: D000051436

- Term: Renal Insufficiency, Chronic

### 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: LOW

- As Found: Unknown

- ID: M6003

- Name: Cholecalciferol

- Relevance: LOW

- As Found: Unknown

- ID: M17558

- Name: Vitamins

- Relevance: LOW

- As Found: Unknown

- ID: T442

- Name: Cholecalciferol

- Relevance: LOW

- As Found: Unknown

- ID: T479

- Name: Vitamin D3

- Relevance: LOW

- As Found: Unknown

- ID: T440

- Name: Calciferol

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
