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| Name | Class |
|---|---|
| Norske Kvinners Sanitetsforening Troms | UNKNOWN |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cholecalciferol (Vitamin D3) | Drug | 20 000 Iu x2/week + calcium 500 mg/cholecalciferol 400 IU x2/d | ||
| placebo | Drug | Calcium 500 mg/Cholecalciferol 400 IU x2/d and placebo 2/w |
| Measure | Description | Time Frame |
|---|---|---|
| changes in bone mineral density in columna and total hip. | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle strength (hand grip strength and knee extension) | One year | |
| balance (tandem test) | One year | |
| body composition (Dexa) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rolf Jorde, Ph.D, M.D | Medical Dpt, University Hospital of Northern Norway | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Dpt. B, University Hospital of Northern Norway | Tromsø | 9012 | Norway |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| One year |
| inflammation markers | One year |
| calcium and vitamin D metabolism | One year |
| blood lipids | One year |
| renal function | One year |
| telomere length | one year |
| perception of own health | one year |
| Urinary tract symptoms | one year |
| effects of polymorphisms in VDR on the other endpoints | one year |
| side effects | one year |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |