NCT00491920

High Dosage Vitamin D and Osteoporosis

High Dosage Vitamin D in the Treatment of Osteoporosis in Postmenopausal Women

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 297 (actual)
• Sponsor: University Hospital of North Norway · Academic / Other
• Sex: Female
• Age: 50 Years – 80 Years
• Healthy volunteers: Accepted

Summary

Vitamin D and calcium are essential in the treatment and prevention of osteoporosis. What dosage of vitamin D which is the ideal one, is not yet clear. We want to test the hypothesis that high dosage of vitamin D (i.e. 6500 IU/d) is better than standard dosage (800 IU/d) in a randomized double-blind trial. We will include 400 postmenopausal otherwise healthy women with T-score \<= -2.0 in L2-4 or mean total hip. Everybody will receive calcium 1000 mg and vitamin D 800 IU every day. Half of the group will also receive vitamin D 40 000 IU/week, while the other half will have placebo. The study period is one year.

Conditions

• Osteoporosis
• Osteopenia

Interventions

Type	Name	Description
DRUG	cholecalciferol (Vitamin D3)	20 000 Iu x2/week \+ calcium 500 mg/cholecalciferol 400 IU x2/d
DRUG	placebo	Calcium 500 mg/Cholecalciferol 400 IU x2/d and placebo 2/w

Timeline

• Start date: 2007-02-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2007-06-26
• Last updated: 2011-11-03

Locations

1 site across 1 country: Norway