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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00718276

Enrollment

Registered

2008-07-18

Start date

2008-03-31

Completion date

2008-09-30

Last updated

2011-12-23

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

Conditions

Healthy

Keywords

Healthy postmenopausal women

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

Detailed description

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

Interventions

DRUG25(OH)D

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

DIETARY_SUPPLEMENTvitamin D3

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

50 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
serum 25(OH)D levels	repeated assessments over 4 months

Secondary

Measure	Time frame
muscle strength, blood pressure, blood glucose, bone markers	repeated assessments over 4 months

Countries

Switzerland

Outcome results

None listed

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