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Completed

NCT Number: NCT00718276

Pharmacokinetic Study: Effect of 25(OH)D and Vitamin D3 on Serum 25(OH)D

We compare the effect of HyD (25-hydroxyvitamin D) and vitamin D3 in their effect on 25-hydroxyvitamin D plasma levels over a course of 4 month. This is a pharmacokinetic study including 35 postmenopausal women.

* Trial with medicinal product

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Key information

Conditions

Healthy

Age range

50 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

University Hospital Zurich, Centre on Aging and Mobility

Zurich, Canton of Zurich, 8091, Switzerland

About this study

We include postmenopausal women age 50 to 75, race/ethnicity: Caucasian, serum 25(OH)D at baseline between 20 to 60 nmol/l, body mass index: < 30 kg/m2

to compare 25(OH)D and vitamin D3 in equimolar doses over a 4 month pharmacokinetic trial. The dosing arms are daily, weekly, and bolus

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Postmenopausal women
  • Age 50 to 75 years
  • Body mass index 18-29 kg/m2
  • 25-hydroxyvitamin D levels 20 to 60 nmol/l
  • Caucasian
  • Generally healthy

Exclusion criteria

  • Serum calcium > 2.6 nmol/L
  • Use if dietary supplements (> 400 IU vitamin D per day, > 600 mg of calcium per day)
  • Hypertension
  • Diseases that carry the risk of hypercalcemia
  • Use of any drug that interferes with bone metabolism in the last 12 months (bisphosphonates estrogen receptor modulators, PTH, calcitonin)
  • Oral HRT in the last 6 months
  • Extreme diets
  • Fracture or fall in the last 3 months
  • Current smoking or alcohol abuse
  • Planning on a sunny vacation in the course of the trial
  • Kidney stone history
  • Creatinine clearance < 30 ml/min
  • Co-medications: anticoagulants, PTH, corticosteroids, thiazide diuretics, digoxin, anticonvulsants, malabsorption,z C

Treatment and study plan

25(OH)D

Drug

daily (20ug), weekly (140 ug), Bolus (140 ug)

Other names: HyD

Vitamin D3

Dietary Supplement

daily (800 IU), weekly (5600 IU), Bolus (5600 Iu)

Other names: Cholecalciferol

Primary outcomes

  1. serum 25(OH)D levels

    Time frame: repeated assessments over 4 months

Secondary outcomes

  1. muscle strength, blood pressure, blood glucose, bone markers

    Time frame: repeated assessments over 4 months

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

Pharmacokinetic Study in Healthy Postmenopausal Women to Compare Supplementation of Vitamin D3 to 25(OH)D

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jul 18, 2008
Registry last updated
Dec 23, 2011

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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