Safety and Bioefficacy of Vitamin D2 and Vitamin D3

Safety and Bioefficacy of Vitamin D2 and Vitamin D3: Randomized Trial With Human Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: cholecalciferol; Dietary supplement: ergocalciferol

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
• Enrollment (Actual): 120
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
change of 25-hydroxvitamin D	after 4 and 8 weeks of supplementation

Collaborators and Investigators

• Sponsor: Ulrike Lehmann

Publications and helpful links

General Publications

• Lehmann U, Hirche F, Stangl GI, Hinz K, Westphal S, Dierkes J. Bioavailability of vitamin D(2) and D(3) in healthy volunteers, a randomized placebo-controlled trial. J Clin Endocrinol Metab. 2013 Nov;98(11):4339-45. doi: 10.1210/jc.2012-4287. Epub 2013 Sep 3.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (ACTUAL): May 1, 2012
• Study Completion (ACTUAL): May 1, 2012

Study Registration Dates

• First Submitted: October 24, 2011
• First Submitted That Met QC Criteria: December 30, 2011
• First Posted (ESTIMATE): January 2, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 10, 2012
• Last Update Submitted That Met QC Criteria: October 7, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: randomized controlled trial; bioavailability; vitamin D
• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Ergocalciferols
• Other Study ID Numbers: BMBF 0315668A