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

Study Overview
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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.

Official Title
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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

Conditions
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Juvenile Rheumatoid Arthritis

Intervention / Treatment
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* Dietary Supplement: Cholecalciferol
* Dietary Supplement: Calcium
* Dietary Supplement: Calcium and cholecalciferol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Juvenile Rheumatoid arthritis Exclusion Criteria: Steroid use

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent true calcium absorption |  | After 6 months of treatment | 

Secondary Outcome Measures

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