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Safety and Bioefficacy of Vitamin D2 and Vitamin D3

This study has been completed.
Information provided by (Responsible Party):
Ulrike Lehmann, Martin-Luther-Universität Halle-Wittenberg Identifier:
First received: October 24, 2011
Last updated: October 7, 2012
Last verified: October 2012
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Ulrike Lehmann, Martin-Luther-Universität Halle-Wittenberg:

Primary Outcome Measures:
  • change of 25-hydroxvitamin D [ Time Frame: after 4 and 8 weeks of supplementation ]

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
Placebo Comparator: Placebo
Placebo for 8 weeks
Dietary Supplement: 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)

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT01503216

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Ulrike Lehmann, Principal Investigator, Martin-Luther-Universität Halle-Wittenberg Identifier: NCT01503216     History of Changes
Other Study ID Numbers: BMBF 0315668A
Study First Received: October 24, 2011
Last Updated: October 7, 2012

Keywords provided by Ulrike Lehmann, Martin-Luther-Universität Halle-Wittenberg:
randomized controlled trial
vitamin D

Additional relevant MeSH terms:
Vitamin D Deficiency
Deficiency Diseases
Nutrition Disorders
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on August 21, 2017