Effect of High-Dose Vitamin D on Bone Density in Osteogenesis Imperfecta
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|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|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01713231
|Shriners Hospitals for Children-Canada|
|Montréal, Quebec, Canada, H3G1A6|