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High Dosage Vitamin D and Osteoporosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00491920
Recruitment Status : Completed
First Posted : June 26, 2007
Last Update Posted : November 3, 2011
Norske Kvinners Sanitetsforening Troms
Information provided by (Responsible Party):
University Hospital of North Norway

Brief 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.

Condition or disease Intervention/treatment Phase
Osteoporosis Osteopenia Drug: cholecalciferol (Vitamin D3) Drug: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 297 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: High Dosage Vitamin D in the Treatment of Osteoporosis in Postmenopausal Women
Study Start Date : February 2007
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

Intervention Details:
  • 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

Primary Outcome Measures :
  1. changes in bone mineral density in columna and total hip. [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Muscle strength (hand grip strength and knee extension) [ Time Frame: One year ]
  2. balance (tandem test) [ Time Frame: One year ]
  3. body composition (Dexa) [ Time Frame: One year ]
  4. inflammation markers [ Time Frame: One year ]
  5. calcium and vitamin D metabolism [ Time Frame: One year ]
  6. blood lipids [ Time Frame: One year ]
  7. renal function [ Time Frame: One year ]
  8. telomere length [ Time Frame: one year ]
  9. perception of own health [ Time Frame: one year ]
  10. Urinary tract symptoms [ Time Frame: one year ]
  11. effects of polymorphisms in VDR on the other endpoints [ Time Frame: one year ]
  12. side effects [ Time Frame: one year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • bone mineral density in L2-4 or mean total hip with T-score <= -2.0

Exclusion Criteria:

  • current use of bisphosphonates, PTH-analogs, estrogen, SERM, p.o. steroids or use of any of these agents last year
  • serum creatinin >110 umol/L
  • systolic blood pressure >175 mmHg or diastolic blod pressure >105
  • serious disease (heart failure, angina pectoris, myocardial infarction, diabetes, mental reduction, granulomatous disease like sarcoidosis, cancer)
  • kidney stone
  • serum calcium > 2.55 mmol/L
  • suspect primary hyperparathyroidism with serum calcium >2.50 mmol/L combined with PTH > 5.0 mmol/L or serum calcium > 2.45 mmol/L combined with PTH >= 7.0 pmol/L

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00491920

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Medical Dpt. B, University Hospital of Northern Norway
Tromsø, Norway, 9012
Sponsors and Collaborators
University Hospital of North Norway
Norske Kvinners Sanitetsforening Troms
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Principal Investigator: Rolf Jorde, Ph.D, M.D Medical Dpt, University Hospital of Northern Norway

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Responsible Party: University Hospital of North Norway Identifier: NCT00491920    
Other Study ID Numbers: 2006-003186-14
First Posted: June 26, 2007    Key Record Dates
Last Update Posted: November 3, 2011
Last Verified: November 2011
Keywords provided by University Hospital of North Norway:
bone mineral density
vitamin D
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents