NCT00491920|CompletedPhase 4
High Dosage Vitamin D and Osteoporosis
High Dosage Vitamin D in the Treatment of Osteoporosis in Postmenopausal Women
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High Dosage Vitamin D in the Treatment of Osteoporosis in Postmenopausal Women
Sponsor study identifier
interventional
297
1 country
1
Study Start
February 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2010
Actual (reported)Study Completion
February 2010
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2010
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2007
Date type not reportedThis date has not been verified as actual or estimated.
June 25, 2007
Actual (reported)June 26, 2007
Actual (reported)February 2010
Actual (reported)February 2010
Actual (reported)changes in bone mineral density in columna and total hip.
One year
Muscle strength (hand grip strength and knee extension)
One year
balance (tandem test)
One year
body composition (Dexa)
One year
inflammation markers
One year
calcium and vitamin D metabolism
One year
20 000 Iu x2/week \+ calcium 500 mg/cholecalciferol 400 IU x2/d
Calcium 500 mg/Cholecalciferol 400 IU x2/d and placebo 2/w
Medical Dpt. B, University Hospital of Northern Norway
Tromsø, 9012, Norway
Rolf Jorde, Ph.D, M.D
Medical Dpt, University Hospital of Northern Norway
297 participants (actual enrollment reported by the registry).
First Submitted
June 25, 2007
First Posted
June 26, 2007
Study Start
February 2007
Date type not reportedThis date has not been verified as actual or estimated.
Immune and Metabolic Effects of Vitamin D Supplementation in Healthy Humans
Contact the study team to confirm eligibility.
Primary Completion
February 2010
Actual (reported)Study Completion
February 2010
Actual (reported)Last Updated
November 3, 2011
Record last verified: 2011-11
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Source: ClinicalTrials.gov.
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