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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00570934
First Posted: December 11, 2007
Last Update Posted: October 10, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Missouri-Columbia
  Purpose
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.

Condition Intervention Phase
Juvenile Rheumatoid Arthritis Dietary Supplement: Cholecalciferol Dietary Supplement: Calcium Dietary Supplement: Calcium and cholecalciferol Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • Percent true calcium absorption [ Time Frame: After 6 months of treatment ]

Secondary Outcome Measures:
  • Bone Mineralization by Dual Energy x-ray absorption [ Time Frame: After 6 months treatment plus 3 month washout ]

Enrollment: 24
Study Start Date: March 1995
Study Completion Date: February 2002
Primary Completion Date: February 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Placebo
order of interventions placebo,calcium, cholecalciferol, calcium plus cholecalciferol
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
Drug: Placebo
Placebo
Experimental: Calcium
order of treatment calcium, placebo, calcium plus cholecalciferol, cholecalciferol
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
Drug: Placebo
Placebo
Experimental: Cholecalciferol
order of treatments cholecalciferol, calcium and Cholecalciferol, placebo, and calcium
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
Drug: Placebo
Placebo
Experimental: Calcium and cholecalciferol
order of treatment calcium and cholecalciferol, cholecalciferol, calcium, 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
Drug: Placebo
Placebo

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Juvenile Rheumatoid arthritis

Exclusion Criteria:

  • Steroid use
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00570934


Locations
United States, Missouri
University of Missouri Hospitals and clinics
Columbia, Missouri, United States, 65203
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Laura S Hillman, MD University of Missouri-Columbia
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT00570934     History of Changes
Other Study ID Numbers: 5387
First Submitted: December 7, 2007
First Posted: December 11, 2007
Last Update Posted: October 10, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Vitamin D
Cholecalciferol
Calcium, Dietary
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents