Safety and Bioefficacy of Vitamin D2 and Vitamin D3

Overview

The aim of this study is to investigate the bioavailability of vitamin D2 and D3 as measured by the increase of the specific hydroxy forms in serum (25(OH)D2 and 25(OH)D3, respectively, and by total 25(OH)D.

Full Title of Study: “Safety and Bioefficacy of Vitamin D2 and Vitamin D3: Randomized Trial With Human Volunteers”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: May 2012

Detailed Description

Study design: Human volunteers will receive supplements containing either vitamin D2 or D3 for a period of 8 weeks. At baseline, after 4 weeks and after 8 weeks, 25(OH)D2, 25(OH)D3 and total 25(OH)D will be measured in serum as the main outcome variables. Additional outcome variables are the Ca concentration in serum, PTH concentration in serum, ambulatory blood pressure and heart rate, and renin expression in peripheral mononuclear cells. Groups/Cohorts Assigned Interventions 1. Placebo group 2. Vitamin D2-group Daily treatment with vitamin d2-supplements (containing 2000 IU per capsule) 3. Vitamin D3-group Daily treatment with vitamin d3-supplements (containing 2000 IU per capsule)

Interventions

  • Dietary Supplement: cholecalciferol
    • cholecalciferol, 2000 IU per day, 8 weeks
  • Dietary Supplement: ergocalciferol
    • vitamin d2, 2000 IU per day for 8 weeks
  • Dietary Supplement: Placebo
    • Placebo

Arms, Groups and Cohorts

  • Experimental: cholecalciferol
    • Human volunteers receiving cholecalciferol (vitamin D3) for 8 weeks
  • Experimental: Ergocalciferol
    • Ergocalciferol 2000 IU per day for 8 weeks
  • Placebo Comparator: Placebo
    • Placebo for 8 weeks

Clinical Trial Outcome Measures

Primary Measures

  • change of 25-hydroxvitamin D
    • Time Frame: after 4 and 8 weeks of supplementation

Participating in This Clinical Trial

Inclusion Criteria

  • 18 years – healthy Exclusion Criteria:

  • supplementation of vitamin d and calcium – hypercalcemia – hypercalciuria – chronical illness (diabetes, kidney diseases, cardiovascular diseases) – serum-creatinine above 115 mmol/l – pregnancy or breastfeeding women

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Ulrike Lehmann
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Ulrike Lehmann, Principal Investigator – Martin-Luther-Universität Halle-Wittenberg
  • Overall Official(s)
    • Jutta Dierkes, Prof. Dr., Study Director, Institut für Agrar- und Ernährungswissenschaften

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