Effect of High-Dose Vitamin D on Bone Density in Osteogenesis Imperfecta
|ClinicalTrials.gov Identifier: NCT01713231|
Recruitment Status : Completed
First Posted : October 24, 2012
Last Update Posted : September 9, 2014
- Overall Objective: To test the hypothesis that oral vitamin D supplementation at higher than currently prescribed doses has a beneficial effect on the skeleton of young patients with osteogenesis imperfecta (OI).
- Specific Aims: 1. To determine whether 12 months of high-dose vitamin D supplementation, compared to standard-dose vitamin D supplementation, increases areal bone mineral density z-scores at the lumbar spine. 2. To examine the effectiveness of high-dose vitamin D supplementation to increase trabecular and cortical bone mineral density at the radius. 3. To examine whether high-dose vitamin D supplementation has an effect on physiological determinants of bone mass (parathyroid hormone, activity of bone metabolism, muscle function).
- Background: In a preliminary cross-sectional study of 282 OI patients we observed an inverse relationship between serum 25-hydroxyvitamin D and parathyroid hormone levels and a positive relationship between circulating levels of 25-hydroxyvitamin D and lumbar spine areal bone mineral density z-scores. This suggested that high-dose vitamin D supplementation would have a beneficial effect on bone density. Most OI patients currently receive oral vitamin D supplementation of 400 International Units per day, but doses of 2000 International Units per day are safe and have been shown to be beneficial in studies on healthy adolescents.
- Study Design: This is a parallel-group double-blind randomized controlled trial of 12 months duration on 60 children and adolescents aged 6 to 19 years with a clinical diagnosis of OI. One group of 30 participants will be randomized to receive vitamin D3 at a dose of 2000 international units per day ('high-dose group'). The other group of 30 participants will be randomized to receive vitamin D3 at a dose of 400 international units per day ('standard-dose group'). Randomization will be stratified according to pubertal status and bisphosphonate treatment status.
- Clinical Relevance: The proposed study aims at direct improvements in the care of OI patients. If a simple and low-cost 'intervention' such as high-dose vitamin D supplementation can be shown to be effective in relieving some of the disease burden associated with OI, the benefit to OI patients worldwide would be substantial.
|Condition or disease||Intervention/treatment||Phase|
|Osteogenesis Imperfecta||Dietary Supplement: standard-dose vitamin D (400IU per day) Dietary Supplement: high-dose vitamin D (2000 IU per day)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Effect of High-Dose Vitamin D on Bone Density in Osteogenesis Imperfecta|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||July 2014|
Active Comparator: standard-dose vitamin D
one group of 30 participants will be randomized to receive vitamin D3 at a dose of 400 international units per day ('standard-dose group').
|Dietary Supplement: standard-dose vitamin D (400IU per day)|
Experimental: high-dose vitamin D
One group of 30 participants will be randomized to receive vitamin D3 at a dose of 2000 international units per day ('high-dose group').
|Dietary Supplement: high-dose vitamin D (2000 IU per day)|
- Change in areal bone mineral density z-score of the lumbar spine [ Time Frame: at baseline and 12 months ]LS-aBMD z-score will be used as the primary outcome.The lumbar spine is the standard site of measurement both in the clinical follow up of OI patients .
- Change in trabecular and cortical volumetric bone mineral density z-scores at the radius, as measured by pQCT, relative to baseline. [ Time Frame: at baseline and at 12 months ]Trabecular bone is analyzed at the distal radial metaphysis ('4% site'). Cortical bone is analyzed at the radial diaphysis ('65% site').
- Percentage change in lower extremity muscle power per body weight, as measured by jumping mechanography, relative to baseline. [ Time Frame: baseline and 12 months ]A countermovement jump to maximal height ('single two-legged jump') will be evaluated. In patients who are unable to jump, the heel-rise test will be used to determine muscle power.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01713231
|Shriners Hospitals for Children-Canada|
|Montréal, Quebec, Canada, H3G1A6|