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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00570934
First received: December 7, 2007
Last updated: August 15, 2016
Last verified: August 2016
  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 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 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 ] [ 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
Primary Completion Date: February 2002 (Final data collection date for primary outcome measure)
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 cholecalciferol, calcium and Cholecalciferol, 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 cholecalciferol, 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

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

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

Inclusion Criteria:

  • Juvenile Rheumatoid arthritis

Exclusion Criteria:

  • Steroid use
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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: 5837 
Study First Received: December 7, 2007
Last Updated: August 15, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
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
Vitamins
Vitamin D
Cholecalciferol
Calcium, Dietary
Calcium Carbonate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents

ClinicalTrials.gov processed this record on August 22, 2016