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Vitamin D Intervention Trial in Healthy Chinese, Phase II

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ClinicalTrials.gov Identifier: NCT01998763
Recruitment Status : Completed
First Posted : December 2, 2013
Last Update Posted : January 22, 2016
Sponsor:
Information provided by (Responsible Party):
Xu Lin, Chinese Academy of Sciences

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. 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

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Dietary Supplement: Placebo Dietary Supplement: Vitamin D3 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 448 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Knowledge Innovation Project of CAS - Genetic and Nutritional Association Studies on Metabolism-related Diseases in Chinese Population -- Vitamin D Intervention Study
Study Start Date : November 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Placebo Comparator: Placebo
5 placebo pills per day, 20 weeks
Dietary Supplement: Placebo
placebo capsules have similar appearance and smell as 400 IU vitamin D3 capsules,

Experimental: 2000 IU/d Vitamin D3
5 vitamin D3 pills per day, 20 weeks
Dietary Supplement: Vitamin D3
Vitamin D3 2000 IU per day




Primary Outcome Measures :
  1. 25-hydroxyvitamin D [ Time Frame: 0,10,20 week ]
    Serum 25(OH)D (D2+D3) concentration was measured by a liquid chromatography-mass spectrometry (LC-MS) method


Secondary Outcome Measures :
  1. calcium [ Time Frame: 0,10,20 week ]
    Serum calcium was measured by an automatic biochemical analyzer

  2. parathyroid hormone [ Time Frame: 0,10,20 week ]
    Serum iPTH was measured by ADVIA Centaur XP Immunoassay System (Siemens, Germany)

  3. Vitamin D binding protein [ Time Frame: 0,10,20 week ]
    Serum VDBP was measured by an ELISA kit



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01998763


Locations
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China
Institute for Nutritional Sciecnes, Chinese Acadamy of Sciences
Shanghai, China
Sponsors and Collaborators
Chinese Academy of Sciences
Investigators
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Principal Investigator: Xu Lin, PhD Institute for Nutritional Sciecnes, Chinese Acadamy of Sciences
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Xu Lin, Principal Investigator, Chinese Academy of Sciences
ClinicalTrials.gov Identifier: NCT01998763    
Other Study ID Numbers: KSCX2-EW-R-10-VDII
KSCX2-EW-R-10 ( Other Grant/Funding Number: Knowledge Innovation Project of CAS )
First Posted: December 2, 2013    Key Record Dates
Last Update Posted: January 22, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Xu Lin, Chinese Academy of Sciences:
Vitamin D3 supplementation
metabolite profile
SNPs
bone-turnover marker
Additional relevant MeSH terms:
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Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents