NCT01998763

Brief 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. 1.vitamin D3 supplement on serum 25(OH)D levels and the modifying factors;
  2. 2.genetic and non-genetic variants on vitamin D bioavailability;
  3. 3.vitamin D3 supplementation on metabolic profiles and circulating bone-turnover markers

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
448

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2013

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

November 25, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 2, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 22, 2016

Status Verified

January 1, 2016

Enrollment Period

6 months

First QC Date

November 25, 2013

Last Update Submit

January 20, 2016

Conditions

Vitamin D Deficiency

Keywords

Vitamin D3 supplementationmetabolite profileSNPsbone-turnover marker

Outcome Measures

Primary Outcomes (1)

  • 25-hydroxyvitamin D

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

    0,10,20 week

Secondary Outcomes (3)

  • calcium

    0,10,20 week

  • parathyroid hormone

    0,10,20 week

  • Vitamin D binding protein

    0,10,20 week

Study Arms (2)

Placebo

PLACEBO COMPARATOR

5 placebo pills per day, 20 weeks

Dietary Supplement: Placebo

2000 IU/d Vitamin D3

EXPERIMENTAL

5 vitamin D3 pills per day, 20 weeks

Dietary Supplement: Vitamin D3

Interventions

PlaceboDIETARY_SUPPLEMENT

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

Placebo
Vitamin D3DIETARY_SUPPLEMENT

Vitamin D3 2000 IU per day

2000 IU/d Vitamin D3

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 20-45 years. with vitamin D deficiency (12.5 ≤ 25(OH)D \< 50 nmol/l)

You may not qualify if:

  • BMI \< 18.5 kg/m2, or BMI ≥ 25 kg/m2
  • Total intake of calcium from diet or supplements \>1200mg/d, or fasting serum calcium level ≥2.75 mmol/l
  • Participating in other clinical studies within previous 3 months
  • Taking vitamin D supplements within previous 3 months
  • Using medications that may affect vitamin D metabolism in previous 3 months;
  • Concomitant with clinical conditions, like liver dysfunction (serum alanine transaminase (ALT) ≥40 U/L; and/or aspartate transaminase (AST) ≥40 U/L; Glutamyl transpeptidase （GGT）≥50 U/L; serum creatinine \< 50 or \> 120 µmol/L; urea nitrogen (UN) \< 7 or \> 18 mg/dl, and/or urine acid \<90 or \>420 µmol/L; which may affect vitamin D metabolism;
  • History of drug or alcohol abuse (\>40 g/d)
  • Women during pregnancy or lactation
  • Individuals with mental disorders or current use of antidepressants, the conditions which may affect him or her understanding and unwillingness to the intervention;
  • Having clinically diagnosed AIDS, hepatitis A, hepatitis B, tuberculosis and other infectious diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Nutritional Sciecnes, Chinese Acadamy of Sciences

Shanghai, China

Location

Related Publications (2)

  • Yao P, Sun L, Xiong Q, Xu X, Li H, Lin X. Cholecalciferol Supplementation Promotes Bone Turnover in Chinese Adults with Vitamin D Deficiency. J Nutr. 2018 May 1;148(5):746-751. doi: 10.1093/jn/nxy032.

    PMID: 29897564DERIVED

  • Yao P, Sun L, Lu L, Ding H, Chen X, Tang L, Xu X, Liu G, Hu Y, Ma Y, Wang F, Jin Q, Zheng H, Yin H, Zeng R, Chen Y, Hu FB, Li H, Lin X. Effects of Genetic and Nongenetic Factors on Total and Bioavailable 25(OH)D Responses to Vitamin D Supplementation. J Clin Endocrinol Metab. 2017 Jan 1;102(1):100-110. doi: 10.1210/jc.2016-2930.

    PMID: 27768857DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Xu Lin, PhD

    Institute for Nutritional Sciecnes, Chinese Acadamy of Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 25, 2013

First Posted

December 2, 2013

Study Start

November 1, 2013

Primary Completion

May 1, 2014

Study Completion

December 1, 2015

Last Updated

January 22, 2016

Record last verified: 2016-01

Locations

CN(1)