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

NCT ID: NCT00570934

Last Updated: 2016-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-03-31

Study Completion Date

2002-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Juvenile Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

order of interventions placebo,calcium, cholecalciferol, calcium plus cholecalciferol

Group Type EXPERIMENTAL

Cholecalciferol

Intervention Type DIETARY_SUPPLEMENT

2000IU Cholecalciferol P.O. Q.D.

Calcium

Intervention Type DIETARY_SUPPLEMENT

1 gm calcium as calcium carbonate

Calcium and cholecalciferol

Intervention Type DIETARY_SUPPLEMENT

2000IU cholecalciferol and 1 gm calcium P.O. Q.D. for 6 months

Placebo

Intervention Type DRUG

Placebo

Calcium

order of treatment calcium, placebo, calcium plus cholecalciferol, cholecalciferol

Group Type EXPERIMENTAL

Cholecalciferol

Intervention Type DIETARY_SUPPLEMENT

2000IU Cholecalciferol P.O. Q.D.

Calcium

Intervention Type DIETARY_SUPPLEMENT

1 gm calcium as calcium carbonate

Calcium and cholecalciferol

Intervention Type DIETARY_SUPPLEMENT

2000IU cholecalciferol and 1 gm calcium P.O. Q.D. for 6 months

Placebo

Intervention Type DRUG

Placebo

Cholecalciferol

order of treatments cholecalciferol, calcium and Cholecalciferol, placebo, and calcium

Group Type EXPERIMENTAL

Cholecalciferol

Intervention Type DIETARY_SUPPLEMENT

2000IU Cholecalciferol P.O. Q.D.

Calcium

Intervention Type DIETARY_SUPPLEMENT

1 gm calcium as calcium carbonate

Calcium and cholecalciferol

Intervention Type DIETARY_SUPPLEMENT

2000IU cholecalciferol and 1 gm calcium P.O. Q.D. for 6 months

Placebo

Intervention Type DRUG

Placebo

Calcium and cholecalciferol

order of treatment calcium and cholecalciferol, cholecalciferol, calcium, placebo

Group Type EXPERIMENTAL

Cholecalciferol

Intervention Type DIETARY_SUPPLEMENT

2000IU Cholecalciferol P.O. Q.D.

Calcium

Intervention Type DIETARY_SUPPLEMENT

1 gm calcium as calcium carbonate

Calcium and cholecalciferol

Intervention Type DIETARY_SUPPLEMENT

2000IU cholecalciferol and 1 gm calcium P.O. Q.D. for 6 months

Placebo

Intervention Type DRUG

Placebo

Interventions

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Cholecalciferol

2000IU Cholecalciferol P.O. Q.D.

Intervention Type DIETARY_SUPPLEMENT

Calcium

1 gm calcium as calcium carbonate

Intervention Type DIETARY_SUPPLEMENT

Calcium and cholecalciferol

2000IU cholecalciferol and 1 gm calcium P.O. Q.D. for 6 months

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Juvenile Rheumatoid arthritis

Exclusion Criteria

* Steroid use
Minimum Eligible Age

3 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Missouri-Columbia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laura S Hillman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

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University of Missouri Hospitals and clinics

Columbia, Missouri, United States

Site Status

Countries

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United States

References

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Hillman LS, Cassidy JT, Chanetsa F, Hewett JE, Higgins BJ, Robertson JD. Percent true calcium absorption, mineral metabolism, and bone mass in children with arthritis: effect of supplementation with vitamin D3 and calcium. Arthritis Rheum. 2008 Oct;58(10):3255-63. doi: 10.1002/art.23809.

Reference Type DERIVED
PMID: 18821668 (View on PubMed)

Other Identifiers

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5387

Identifier Type: -

Identifier Source: org_study_id

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