A Study on Oral Vitamin D Megadoses

March 26, 2012 updated by: Ville-Valtteri Välimäki, Helsinki University Central Hospital

A Randomized, Double-blind, Placebo-controlled Study on Oral Vitamin D Megadoses - 100 000 or 200 000 IU Vitamin D3 Every Three Months

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, FI-00029 HUS
        • Division of Endocrinology, Department of Medicine, Helsinki University Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • female
  • 70-80 yrs old

Exclusion Criteria:

  • disease or medication affecting calcium homeostasis
  • renal failure (Pt-GFRe-CG < 35 ml/min)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 200 000 IU vitamin D3 every three months
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 Names:
  • Vigantol vitamin D3 (cholecalciferol) oil 20 000 IU/ml
Dietary supplement: calcium carbonate
1000 mg calcium per os every day for one year
Experimental: 100 000 IU vitamin D3 every three months
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 Names:
  • Vigantol vitamin D3 (cholecalciferol) oil 20 000 IU/ml
Dietary supplement: calcium carbonate
1000 mg calcium per os every day 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
Placebo Comparator: placebo every three months
Dietary supplement: calcium carbonate
1000 mg calcium per os every day 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum 25(OH)D3 concentration in relation to the target levels of 50-75 nmol/L
Time Frame: 12 months (including 9 time points)
12 months (including 9 time points)

Secondary Outcome Measures

Outcome Measure
Time Frame
Decline of creatine clearance (Pt-GFRe-CG) >20% from baseline
Time Frame: 12 months (including 9 timepoints)
12 months (including 9 timepoints)
Hypercalciuria (dU-Ca >10 mmol/24h)
Time Frame: 12 months (including 9 timepoints)
12 months (including 9 timepoints)
Hypercalcemia (S-Ca-ion >1,3 mmol/l)
Time Frame: 12 months (including 9 timepoints)
12 months (including 9 timepoints)
Serum PTH
Time Frame: 12 months (including 9 timepoints)
12 months (including 9 timepoints)
Serum PINP
Time Frame: 12 months (including 5 timepoints)
12 months (including 5 timepoints)
Serum CTX
Time Frame: 12 months (including 5 timepoints)
12 months (including 5 timepoints)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

February 11, 2010

First Submitted That Met QC Criteria

February 11, 2010

First Posted (Estimate)

February 12, 2010

Study Record Updates

Last Update Posted (Estimate)

March 27, 2012

Last Update Submitted That Met QC Criteria

March 26, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUS-S-D-II
  • 2009-018139-98 (EudraCT Number)
  • KLnro 1/2010 (Other Identifier: The Finnish Medicines Agency Fimea)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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