Safety and Bioefficacy of Vitamin D2 and Vitamin D3

Vitamin D Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01503216
• Other study ID #: BMBF 0315668A
• Status: Completed
• Phase: N/A
• First received: October 24, 2011
• Last updated: October 7, 2012
• Start date: January 2012
• Est. completion date: May 2012

Study information

• Verified date: October 2012
• Source: Martin-Luther-Universität Halle-Wittenberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Food, Agriculture and Consumer Protection
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ulrike Lehmann

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of 25-hydroxvitamin D		after 4 and 8 weeks of supplementation	No