Significant generalized osteopenia develops during childhood or adolescence in some 40% of JRA patients. Attainment of life long peak bone mass occurs during adolescence for females and has been shown to be decreased in many JRA patients. There are neither accepted treatments nor controlled trials addressing osteopenia in JRA patients. Observational studies in JRA patients document high prevalence of suboptimal dietary intake of calcium (Ca) and vitamin D, significantly lower gastrointestinal Ca absorption and low bone formation rate. In JRA patients, daily oral supplementation of 1000 mg of Ca (Ca carbonate) and 400 I.U. of vitamin D for 24 months will result in at least a 10% greater increase in total body bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DXA) compared to treatment with placebo and 400 I.U. vitamin D and this increased BMD will persist for at least 18 months after cessation of the trial. In addition, this project will determine the effect of Ca supplementation on bone physiology by measuring by measuring serum and urinary bone related minerals (Ca, phosphorus), hormones (parathyroid and vitamin D's), bone formation markers (osteocalcin, skeletal alkaline phosphatase), and bone resorption markers (urinary Ca/creatinine and pyridinoline crosslinks). The effects of variants of the vitamin D receptor allele on bone physiology and response to Ca supplementation will also be determined. 185 of the proposed study population of 192 JRA patients meeting eligibility criteria have been enrolled in this prospective, randomized, double-blind, placebo-controlled, 24-month clinical trial (RCT). The participants will also be evaluated 6 and 18 months following the RCT for persistence of treatment effect. To assess effectiveness of randomization and ongoing equality of treatment groups, baseline anthropometrics, pubertal status, physical activity and trial medication compliance will be performed. The baseline characteristics of the treatment groups were compared after a statistician not involved in the study randomized 125. The treatment groups were similar in all demographic parameters except for age at time of enrollment. This statistician adjusted the enrollment for subsequent participants and has balanced the treatment groups for age at enrollment. In addition to standard pill counts, compliance will be assessed (qualitative and quantitative) by the use of microelectronic monitoring and recording of medication container opening. This compliance data will be utilized during the trial to improve patient compliance and in analysis as a covariate affecting outcome.

Project Start
2000-12-01
Project End
2001-11-30
Budget Start
Budget End
Support Year
8
Fiscal Year
2001
Total Cost
$28,540
Indirect Cost
Name
Cincinnati Children's Hospital Medical Center
Department
Type
DUNS #
071284913
City
Cincinnati
State
OH
Country
United States
Zip Code
45229
Natarajan, Girija; Shankaran, Seetha; Laptook, Abbot R et al. (2018) Association between sedation-analgesia and neurodevelopment outcomes in neonatal hypoxic-ischemic encephalopathy. J Perinatol 38:1060-1067
Askie, Lisa M; Darlow, Brian A; Finer, Neil et al. (2018) Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration. JAMA 319:2190-2201
DiFrancesco, Mark W; Shamsuzzaman, Abu; McConnell, Keith B et al. (2018) Age-related changes in baroreflex sensitivity and cardiac autonomic tone in children mirrored by regional brain gray matter volume trajectories. Pediatr Res 83:498-505
Autmizguine, Julie; Tan, Sylvia; Cohen-Wolkowiez, Michael et al. (2018) Antifungal Susceptibility and Clinical Outcome in Neonatal Candidiasis. Pediatr Infect Dis J 37:923-929
Jilling, Tamas; Ambalavanan, Namasivayam; Cotten, C Michael et al. (2018) Surgical necrotizing enterocolitis in extremely premature neonates is associated with genetic variations in an intergenic region of chromosome 8. Pediatr Res 83:943-953
Lin, Shan; Luo, Roger T; Shrestha, Mahesh et al. (2017) The full transforming capacity of MLL-Af4 is interlinked with lymphoid lineage commitment. Blood 130:903-907
Puopolo, Karen M; Mukhopadhyay, Sagori; Hansen, Nellie I et al. (2017) Identification of Extremely Premature Infants at Low Risk for Early-Onset Sepsis. Pediatrics 140:
Lin, Shan; Ptasinska, Anetta; Chen, Xiaoting et al. (2017) A FOXO1-induced oncogenic network defines the AML1-ETO preleukemic program. Blood 130:1213-1222
James, Jennifer; Munson, David; DeMauro, Sara B et al. (2017) Outcomes of Preterm Infants following Discussions about Withdrawal or Withholding of Life Support. J Pediatr 190:118-123.e4
Peralta-Carcelen, Myriam; Carlo, Waldemar A; Pappas, Athina et al. (2017) Behavioral Problems and Socioemotional Competence at 18 to 22 Months of Extremely Premature Children. Pediatrics 139:

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