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Supplimentation With 2000IU Vitamin D, 1gm Calcium or Both on Calcium Absorption and BMC in Children With JRA

This study has been completed.
Sponsor:
Information provided by:
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00570934
First received: December 7, 2007
Last updated: December 10, 2007
Last verified: December 2007
History of Changes
  Purpose

2000IU vitamin D, 1gm calcium, or both given to children with Juvenile Rheumatoid Arthritis 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 Carbonate
Dietary Supplement: 2000IU cholecalciferol plus 1 gm calcium
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect ofSupplimentation With 2000IU Vitamin D, 1gm Calcium or Both on Calcium Absorption and Bone Mineralization in Children With Juvenile Rheumatoid Arthritis

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Percent true calcium absorption [ Time Frame: After 6 months of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bone Mineralization by Dual Energy x-ray absorption [ Time Frame: After 6 months treatment plus 3 month washout ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: March 1995
Study Completion Date: February 2002
Arms Assigned Interventions
Experimental: 1
order of interventions placebo,calcium, cholecalciferol, calcium plus cholecalciferol
 Dietary Supplement: Cholecalciferol
2000IU Cholecalciferol P.O. Q.D.
Dietary Supplement: Calcium Carbonate
1 gm calcium as calcium carbonate
Dietary Supplement: 2000IU cholecalciferol plus 1 gm calcium
2000IU cholecalciferol and 1 gm calcium P.O. Q.D. for 6 months
Experimental: 2
order of treatment calcium, placebo, calcium plus cholecalciferol, cholecalciferol
 Dietary Supplement: Cholecalciferol
2000IU Cholecalciferol P.O. Q.D.
Dietary Supplement: Calcium Carbonate
1 gm calcium as calcium carbonate
Dietary Supplement: 2000IU cholecalciferol plus 1 gm calcium
2000IU cholecalciferol and 1 gm calcium P.O. Q.D. for 6 months
Experimental: 3
order of treatments cholechalciferol, calcium and Cholechalciferol, placebo, and calcium
 Dietary Supplement: Cholecalciferol
2000IU Cholecalciferol P.O. Q.D.
Dietary Supplement: Calcium Carbonate
1 gm calcium as calcium carbonate
Dietary Supplement: 2000IU cholecalciferol plus 1 gm calcium
2000IU cholecalciferol and 1 gm calcium P.O. Q.D. for 6 months
Experimental: 4
order of treatment calcium and cholechalciferol, cholecalciferol, calcium, placebo
 Dietary Supplement: Cholecalciferol
2000IU Cholecalciferol P.O. Q.D.
Dietary Supplement: Calcium Carbonate
1 gm calcium as calcium carbonate
Dietary Supplement: 2000IU cholecalciferol plus 1 gm calcium
2000IU cholecalciferol and 1 gm calcium P.O. Q.D. for 6 months

  Eligibility

Ages Eligible for Study:   3 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Juvenile Rheumatoid arthritis

Exclusion Criteria:

  • Steroid use
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University of Missouri-Columbia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Laura S. Hillman MD, University of Missouri
ClinicalTrials.gov Identifier: NCT00570934     History of Changes
Other Study ID Numbers: hillmanlJRA
Study First Received: December 7, 2007
Last Updated: December 10, 2007
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 18, 2013