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A Study on Oral Vitamin D Megadoses

NCT01067898 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2012-03-27

No results posted yet for this study

Summary

The purpose of this study is to determine if infrequent administration of oral vitamin D megadoses is effective treatment to maintain serum 25-hydroxyvitamin D(3) above target levels of 50-75 nmol/L. The investigators hypothesize that 100 000 IU or at least 200 000 IU vitamin D3 in every three months would be effective and safe treatment to achieve the target levels.

Conditions

  • Hypovitaminosis D

Interventions

DIETARY_SUPPLEMENT

vitamin D3 (cholecalciferol)

vitamin D3 (cholecalciferol) oil 20 000 IU/ml, oral dose of 200 000 IU or 100 000 IU (10ml or 5ml) every three months for one year.

OTHER

olive oil

10 ml (placebo group) or 5 ml (100 000 IU vitamin D3 group) oil per os every three months for one year

DIETARY_SUPPLEMENT

calcium carbonate

1000 mg calcium per os every day for one year

Sponsors & Collaborators

  • Helsinki University Central Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • Finland

Study Locations

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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 NCT01067898 on ClinicalTrials.gov