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Vitamin D Intervention Trial in Healthy Chinese, Phase II

NCT01998763 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 448

Last updated 2016-01-22

No results posted yet for this study

Summary

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

Conditions

  • Vitamin D Deficiency

Interventions

DIETARY_SUPPLEMENT

Placebo

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

DIETARY_SUPPLEMENT

Vitamin D3

Vitamin D3 2000 IU per day

Sponsors & Collaborators

  • Chinese Academy of Sciences

    lead OTHER_GOV

Principal Investigators

  • Xu Lin, PhD · Institute for Nutritional Sciecnes, Chinese Acadamy of Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2014-05-31
Completion
2015-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01998763 on ClinicalTrials.gov