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Clinical Trial Details

Trial ID: L4449
Source ID: NCT01277913
Associated Drug: Vitamin D3
Title: The Effect of Supplementation With Two Different Doses of Vitamin D on Bone Mineral Density, Vitamin D Levels and Hand Grip Strength in Children With Diabetes Mellitus Type 1
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus Type 1
Interventions: DRUG: Vitamin D3|DRUG: Vitamin D3
Outcome Measures: Primary: Percentage of patients with normal bone mineral density (z-score>-1)at lumbar spine(L2-L4)and total body after 12mo of supplementation, Bone mineral density will be assessed with DEXA (dual energy X ray absorptiometry)method at the beginning of the study and after 12 month of supplementation with vitamin D, 12 month|Percentage of patients with adequate 25 hydroxyvitamin level ( >50 ng/ml), every 3 month in spring summer autumn and winter each patient will have blood testing for the serum level of 25hydroxyvitamin D., 12 month|Mean bone mineral density z-score (L2-L4, total body) after 12 mo of supplementation, Bone mineral density will be assessed with DEXA (dual energy X ray absorptiometry)method at the beginning of the study and after 12 month of supplementation with vitamin D, 12 month|Mean isometric hand grip force, assessed at 6 and 12 mo of supplementation, 12 month | Secondary: Mean bone mineral density change after 12 mo of supplementation, 12 mo|Mean serum level of TNF-alfa, osteoprotegerin, IL-6, 12 mo|Mean HBA1C level, HBA1c level will be assessed at summer,spring,autumn and winter., 12 mo|% patients with HbA1C < 7,5 mg%, 12 mo|% patients with vitamin D hypervitaminosis (>200 ng/ml (500 nmol/L) and or hypercalcemia (>2.7 mmol/l) assessed at summer,spring, autumn, and winter, it will be assessed at summer,spring, autumn, and winter, 12 mo
Sponsor/Collaborators: Sponsor: Medical University of Warsaw
Gender: ALL
Age: CHILD
Phases: PHASE4
Enrollment: 60
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2011-01
Completion Date: 2013-11
Results First Posted:
Last Update Posted: 2013-11-05
Locations: Department of Pediatrics, Warsaw, 01-410, Poland
URL: https://clinicaltrials.gov/show/NCT01277913