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Report for Clinical Trial NCT01998763

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Knowledge Innovation Project of CAS - Genetic and Nutritional Association Studies on Metabolism-related Diseases in Chinese Population -- Vitamin D Intervention Study

This is a double-blind, randomized, placebo-controlled trial. Based on inclusion and exclusion criteria, 400 eligible volunteers, who were 20-45 years, with 25-hydroxyvitamin D between 12.5-50 nmol/L and BMI between 18.5-28 kg/m2, were enrolled and randomly assigned to placebo or 2000 IU/d vitamin D3 arm, after taking placebo for one week. The study protocol was approved by the Ethics Committee of Huadong Hospital Affiliated to Fudan University, Shanghai and all participants provided written informed consents.In this 2-arm RCT we aimed to systematically investigate the effect of: 1. vitamin D3 supplement on serum 25(OH)D levels and the modifying factors; 2. genetic and non-genetic variants on vitamin D bioavailability; 3. vitamin D3 supplementation on metabolic profiles and circulating bone-turnover markers

NCT01998763 Vitamin D Deficiency
MeSH: Vitamin D Deficiency
HPO: Low levels of vitamin D

2 Interventions

Name: Placebo

Description: placebo capsules have similar appearance and smell as 400 IU vitamin D3 capsules,

Type: Dietary Supplement

Placebo

Name: Vitamin D3

Description: Vitamin D3 2000 IU per day

Type: Dietary Supplement

2000 IU/d Vitamin D3


Primary Outcomes

Description: Serum 25(OH)D (D2+D3) concentration was measured by a liquid chromatography-mass spectrometry (LC-MS) method

Measure: 25-hydroxyvitamin D

Time: 0,10,20 week

Secondary Outcomes

Description: Serum calcium was measured by an automatic biochemical analyzer

Measure: calcium

Time: 0,10,20 week

Description: Serum iPTH was measured by ADVIA Centaur XP Immunoassay System (Siemens, Germany)

Measure: parathyroid hormone

Time: 0,10,20 week

Description: Serum VDBP was measured by an ELISA kit

Measure: Vitamin D binding protein

Time: 0,10,20 week

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There are 3 SNPs

SNPs


1 rs1790349

In addition, we developed a genetic risk score (GRS) to evaluate the combined effect of three SNPs (rs4588, rs1790349 and rs2060793) from GC, NADSYN1/DHCR7 and CYP2R.


2 rs2060793

In addition, we developed a genetic risk score (GRS) to evaluate the combined effect of three SNPs (rs4588, rs1790349 and rs2060793) from GC, NADSYN1/DHCR7 and CYP2R.


3 rs4588

In addition, we developed a genetic risk score (GRS) to evaluate the combined effect of three SNPs (rs4588, rs1790349 and rs2060793) from GC, NADSYN1/DHCR7 and CYP2R.



HPO Nodes


HPO:
Low levels of vitamin D
Genes 8
RPL11 MST1 RPS10 TCF4 OCRL ACOX2 FARSB GPR35