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Completed

NCT Number: NCT01503216

Safety and Bioefficacy of Vitamin D2 and Vitamin D3

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.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

  • Placebo group
  • Vitamin D2-group Daily treatment with vitamin d2-supplements (containing 2000 IU per capsule)
  • Vitamin D3-group Daily treatment with vitamin d3-supplements (containing 2000 IU per capsule)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cholecalciferol

Dietary Supplement

cholecalciferol, 2000 IU per day, 8 weeks

Other names: Cholecalciferol, vitamin D3

ergocalciferol

Dietary Supplement

vitamin d2, 2000 IU per day for 8 weeks

Placebo

Dietary Supplement

Placebo

Primary outcomes

  1. change of 25-hydroxvitamin D

    Time frame: after 4 and 8 weeks of supplementation

Sponsors and collaborators

Lead sponsor

Ulrike Lehmann

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 2, 2012
Registry last updated
Oct 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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