Safety and Bioefficacy of Vitamin D2 and Vitamin D3

Ulrike Lehmann

Status: Completed

Conditions: Vitamin D Deficiency

Treatments: Dietary Supplement: Placebo; Dietary Supplement: ergocalciferol; Dietary Supplement: cholecalciferol

Study type: Interventional

Funder types: Other

Identifiers

NCT01503216

BMBF 0315668A

Details and patient eligibility

About

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.

Full 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)

Enrollment: 120 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups, including a placebo group

cholecalciferol

Experimental group

Description:

Human volunteers receiving cholecalciferol (vitamin D3) for 8 weeks

Treatment:

Dietary Supplement: cholecalciferol

Ergocalciferol

Experimental group

Description:

Ergocalciferol 2000 IU per day for 8 weeks

Treatment:

Dietary Supplement: ergocalciferol

Placebo

Placebo Comparator group

Description:

Placebo for 8 weeks

Treatment:

Dietary Supplement: Placebo