Pharmacokinetic Study: Effect of 25(OH)D and Vitamin D3 on Serum 25(OH)D
Pharmacokinetic Study in Healthy Postmenopausal Women to Compare Supplementation of Vitamin D3 to 25(OH)D
1 other identifier
interventional
35
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Mar 2008
Typical duration for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 17, 2008
CompletedFirst Posted
Study publicly available on registry
July 18, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedDecember 23, 2011
December 1, 2011
5 months
July 17, 2008
December 22, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
serum 25(OH)D levels
repeated assessments over 4 months
Secondary Outcomes (1)
muscle strength, blood pressure, blood glucose, bone markers
repeated assessments over 4 months
Study Arms (2)
1
ACTIVE COMPARATOR25(OH)D
2
ACTIVE COMPARATORvitamin D3
Interventions
daily (800 IU), weekly (5600 IU), Bolus (5600 Iu)
Eligibility Criteria
You may qualify if:
- Postmenopausal women
- Age 50 to 75 years
- Body mass index 18-29 kg/m2
- hydroxyvitamin D levels 20 to 60 nmol/l
- Caucasian
- Generally healthy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Zurich, Centre on Aging and Mobility
Zurich, Canton of Zurich, 8091, Switzerland
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Heike Bischoff Ferrari, MD, MPH
University Hospital Zurich, Centre on Aging and Mobility
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2008
First Posted
July 18, 2008
Study Start
March 1, 2008
Primary Completion
August 1, 2008
Study Completion
September 1, 2008
Last Updated
December 23, 2011
Record last verified: 2011-12