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High Dosage Vitamin D and Osteoporosis

NCT00491920 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 297

Last updated 2011-11-03

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Norske Kvinners Sanitetsforening Troms

    collaborator UNKNOWN

  • University Hospital of North Norway

    lead OTHER

Principal Investigators

  • Rolf Jorde, Ph.D, M.D · Medical Dpt, University Hospital of Northern Norway

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • Norway

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00491920 on ClinicalTrials.gov