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

Study Overview
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Brief Summary
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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

Detailed Description
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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

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: 25(OH)D
* Dietary Supplement: vitamin D3


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>25(OH)D | Drug: 25(OH)D<br>* daily (20ug), weekly (140 ug), Bolus (140 ug)<br>* Other names: HyD;|
| Active Comparator: 2<br>vitamin D3 | Dietary Supplement: vitamin D3<br>* daily (800 IU), weekly (5600 IU), Bolus (5600 Iu)<br>* Other names: Cholecalciferol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum 25(OH)D levels |  | repeated assessments over 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| muscle strength, blood pressure, blood glucose, bone markers |  | repeated assessments over 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy postmenopausal women