Safety and Bioefficacy of Vitamin D2 and Vitamin D3

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ulrike Lehmann, Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier:
NCT01503216
First received: October 24, 2011
Last updated: October 7, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Vitamin D Deficiency
Dietary Supplement: cholecalciferol
Dietary Supplement: ergocalciferol
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Health Services Research
Official Title: Safety and Bioefficacy of Vitamin D2 and Vitamin D3: Randomized Trial With Human Volunteers

Resource links provided by NLM:


Further study details as provided by Martin-Luther-Universität Halle-Wittenberg:

Primary Outcome Measures:
  • change of 25-hydroxvitamin D [ Time Frame: after 4 and 8 weeks of supplementation ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: January 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cholecalciferol
Human volunteers receiving cholecalciferol (vitamin D3) for 8 weeks
Dietary Supplement: cholecalciferol
cholecalciferol, 2000 IU per day, 8 weeks
Other Name: Cholecalciferol, vitamin D3
Experimental: Ergocalciferol
Ergocalciferol 2000 IU per day for 8 weeks
Dietary Supplement: ergocalciferol
vitamin d2, 2000 IU per day for 8 weeks
Other Name: ergocalciferol
Placebo Comparator: Placebo
Placebo for 8 weeks
Dietary Supplement: Placebo
Placebo
Other Name: Placebo

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)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01503216

Sponsors and Collaborators
Ulrike Lehmann
Investigators
Study Director: Jutta Dierkes, Prof. Dr. Institut für Agrar- und Ernährungswissenschaften
  More Information

No publications provided by Martin-Luther-Universität Halle-Wittenberg

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ulrike Lehmann, Principal Investigator, Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier: NCT01503216     History of Changes
Other Study ID Numbers: BMBF 0315668A
Study First Received: October 24, 2011
Last Updated: October 7, 2012
Health Authority: Germany: Federal Ministry of Food, Agriculture and Consumer Protection

Keywords provided by Martin-Luther-Universität Halle-Wittenberg:
randomized controlled trial
vitamin D
bioavailability

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on April 17, 2014