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High Dosage Vitamin D and Osteoporosis

This study has been completed.
Sponsor:
Collaborator:
Norske Kvinners Sanitetsforening Troms
Information provided by (Responsible Party):
University Hospital of North Norway
ClinicalTrials.gov Identifier:
NCT00491920
First received: June 25, 2007
Last updated: November 2, 2011
Last verified: November 2011

June 25, 2007
November 2, 2011
February 2007
February 2010   (final data collection date for primary outcome measure)
changes in bone mineral density in columna and total hip. [ Time Frame: One year ] [ Designated as safety issue: No ]
changes in bone mineral density in columna and total hip. [ Time Frame: One year ]
Complete list of historical versions of study NCT00491920 on ClinicalTrials.gov Archive Site
  • Muscle strength (hand grip strength and knee extension) [ Time Frame: One year ] [ Designated as safety issue: No ]
  • balance (tandem test) [ Time Frame: One year ] [ Designated as safety issue: No ]
  • body composition (Dexa) [ Time Frame: One year ] [ Designated as safety issue: No ]
  • inflammation markers [ Time Frame: One year ] [ Designated as safety issue: No ]
  • calcium and vitamin D metabolism [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • blood lipids [ Time Frame: One year ] [ Designated as safety issue: No ]
  • renal function [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • telomere length [ Time Frame: one year ] [ Designated as safety issue: No ]
  • perception of own health [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Urinary tract symptoms [ Time Frame: one year ] [ Designated as safety issue: No ]
  • effects of polymorphisms in VDR on the other endpoints [ Time Frame: one year ] [ Designated as safety issue: No ]
  • side effects [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • Muscle strength (hand grip strength and knee extension) [ Time Frame: One year ]
  • balance (tandem test) [ Time Frame: One year ]
  • body composition (Dexa) [ Time Frame: One year ]
  • inflammation markers [ Time Frame: One year ]
  • calcium and vitamin D metabolism [ Time Frame: One year ]
  • blood lipids [ Time Frame: One year ]
  • renal function [ Time Frame: One year ]
Not Provided
Not Provided
 
High Dosage Vitamin D and Osteoporosis
High Dosage Vitamin D in the Treatment of Osteoporosis in Postmenopausal Women

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Osteoporosis
  • Osteopenia
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
297
February 2010
February 2010   (final data collection date for primary outcome measure)

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
Female
50 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00491920
2006-003186-14
No
University Hospital of North Norway
University Hospital of North Norway
Norske Kvinners Sanitetsforening Troms
Principal Investigator: Rolf Jorde, Ph.D, M.D Medical Dpt, University Hospital of Northern Norway
University Hospital of North Norway
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP