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

Sponsored by:	University of Missouri-Columbia
Information provided by:	University of Missouri-Columbia
ClinicalTrials.gov Identifier:	NCT00570934

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 III

MedlinePlus related topics: Calcium Dietary Supplements Juvenile Rheumatoid Arthritis Rheumatoid Arthritis

Drug Information available for: Calcium gluconate Vitamin D Ergocalciferol Calcium carbonate Cholecalciferol

U.S. FDA Resources

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

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
1: Experimental 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
2: Experimental 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
3: Experimental 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
4: Experimental 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

Publications indexed to this study:

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.

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

Study placed in the following topic categories:

Cholecalciferol
Arthritis, Juvenile Rheumatoid
Autoimmune Diseases
Joint Diseases
Arthritis, Rheumatoid
Ergocalciferols
Rheumatic Diseases

Calcium Carbonate
Calcium, Dietary
Vitamin D
Musculoskeletal Diseases
Arthritis
Connective Tissue Diseases

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Growth Substances
Vitamins
Physiological Effects of Drugs

Antacids
Bone Density Conservation Agents
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009