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Safety and Bioefficacy of Vitamin D2 and Vitamin D3

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ClinicalTrials.gov Identifier: NCT01503216
Recruitment Status : Completed
First Posted : January 2, 2012
Last Update Posted : October 10, 2012
Sponsor:
Information provided by (Responsible Party):
Ulrike Lehmann, Martin-Luther-Universität Halle-Wittenberg

Brief Summary:
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 or disease Intervention/treatment Phase
Vitamin D Deficiency Dietary Supplement: cholecalciferol Dietary Supplement: ergocalciferol Dietary Supplement: Placebo Not Applicable

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)

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
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
Study Start Date : January 2012
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
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
Placebo




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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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): NCT01503216


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

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
First Posted: January 2, 2012    Key Record Dates
Last Update Posted: October 10, 2012
Last Verified: October 2012

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

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