Safety and Bioefficacy of Vitamin D2 and Vitamin D3

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01503216

Enrollment

120

Registered

2012-01-02

Start date

2012-01-31

Completion date

2012-05-31

Last updated

2012-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin D Deficiency

Keywords

randomized controlled trial, vitamin D, bioavailability

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.

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)

Interventions

DIETARY_SUPPLEMENTcholecalciferol

cholecalciferol, 2000 IU per day, 8 weeks

DIETARY_SUPPLEMENTergocalciferol

vitamin d2, 2000 IU per day for 8 weeks

DIETARY_SUPPLEMENTPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026