Supplementation With Vitamin D, Calcium or Both on Calcium Absorption and Bone Mineral Content in Children With JRA

October 7, 2016 updated by: University of Missouri-Columbia

Effect of Supplementation With 2000 International Units (IU) Vitamin D, 1gm Calcium or Both on Calcium Absorption and Bone Mineralization in Children With Juvenile Rheumatoid Arthritis

2000 international units (IU) vitamin D, 1 gram (gm) calcium, or both given to children with Juvenile Rheumatoid Arthritis (JRA) may increase percent true calcium absorption, bone mineral turnover and/or bone mineralization.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Supplementation With 2000 IU Vitamin D, 1 gm Calcium or Both on Calcium Absorption and Bone Mineralization in Children With Juvenile Rheumatoid Arthritis may increase percent true calcium absorption, bone mineral turnover and/or bone mineralization.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 3

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

  • United States
    • Missouri
      • Columbia, Missouri, United States, 65203
        • University of Missouri Hospitals and Clinics

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

3 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Juvenile Rheumatoid arthritis

Exclusion Criteria:

  • Steroid use

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: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Placebo
order of interventions placebo,calcium, cholecalciferol, calcium plus cholecalciferol
Drug: Placebo
Placebo
Dietary supplement: Cholecalciferol
2000IU Cholecalciferol P.O. Q.D.
Dietary supplement: Calcium
1 gm calcium as calcium carbonate
Dietary supplement: Calcium and cholecalciferol
2000IU cholecalciferol and 1 gm calcium P.O. Q.D. for 6 months
Experimental: Calcium
order of treatment calcium, placebo, calcium plus cholecalciferol, cholecalciferol
Drug: Placebo
Placebo
Dietary supplement: Cholecalciferol
2000IU Cholecalciferol P.O. Q.D.
Dietary supplement: Calcium
1 gm calcium as calcium carbonate
Dietary supplement: Calcium and cholecalciferol
2000IU cholecalciferol and 1 gm calcium P.O. Q.D. for 6 months
Experimental: Cholecalciferol
order of treatments cholecalciferol, calcium and Cholecalciferol, placebo, and calcium
Drug: Placebo
Placebo
Dietary supplement: Cholecalciferol
2000IU Cholecalciferol P.O. Q.D.
Dietary supplement: Calcium
1 gm calcium as calcium carbonate
Dietary supplement: Calcium and cholecalciferol
2000IU cholecalciferol and 1 gm calcium P.O. Q.D. for 6 months
Experimental: Calcium and cholecalciferol
order of treatment calcium and cholecalciferol, cholecalciferol, calcium, placebo
Drug: Placebo
Placebo
Dietary supplement: Cholecalciferol
2000IU Cholecalciferol P.O. Q.D.
Dietary supplement: Calcium
1 gm calcium as calcium carbonate
Dietary supplement: Calcium and cholecalciferol
2000IU cholecalciferol and 1 gm calcium P.O. Q.D. for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent true calcium absorption
Time Frame: After 6 months of treatment
After 6 months of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Bone Mineralization by Dual Energy x-ray absorption
Time Frame: After 6 months treatment plus 3 month washout
After 6 months treatment plus 3 month washout

Collaborators and Investigators

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

Sponsor

University of Missouri-Columbia

Investigators

  • Principal Investigator: Laura S Hillman, MD, University of Missouri-Columbia

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

March 1, 1995

Primary Completion (Actual)

February 1, 2002

Study Completion (Actual)

February 1, 2002

Study Registration Dates

First Submitted

December 7, 2007

First Submitted That Met QC Criteria

December 10, 2007

First Posted (Estimate)

December 11, 2007

Study Record Updates

Last Update Posted (Estimate)

October 10, 2016

Last Update Submitted That Met QC Criteria

October 7, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5387

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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