Trial record 2 of 4 for: Open Studies | "Osteogenesis Imperfecta"
Effect of High-Dose Vitamin D on Bone Density in Osteogenesis Imperfecta
This study is currently recruiting participants.
Verified October 2012 by Shriners Hospitals for Children
Louis-Nicolas Veilleux Ph.D.
Information provided by (Responsible Party):
Louis-Nicolas Veilleux Ph.D., Shriners Hospitals for Children
First received: October 21, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
- 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.
Dietary Supplement: standard-dose vitamin D (400IU per day)
Dietary Supplement: high-dose vitamin D (2000 IU per day)
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||Effect of High-Dose Vitamin D on Bone Density in Osteogenesis Imperfecta|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Shriners Hospitals for Children:
Primary Outcome Measures:
- Change in areal bone mineral density z-score of the lumbar spine [ Time Frame: at baseline and 12 months ] [ Designated as safety issue: No ]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 .
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]Trabecular bone is analyzed at the distal radial metaphysis ('4% site'). Cortical bone is analyzed at the radial diaphysis ('65% site').
Other Outcome Measures:
- Percentage change in lower extremity muscle power per body weight, as measured by jumping mechanography, relative to baseline. [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]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.
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
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)|
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01713231
|Contact: Louis-Nicolas Veilleux, PhD||+1 514 firstname.lastname@example.org|
|Contact: Laura Plante, MSc||+1 514 email@example.com|
|Shriners Hospitals for Children-Canada||Recruiting|
|Montréal, Quebec, Canada, H3G1A6|
|Contact: Marie-Josée Giguère, MSc +1 514 2828249 firstname.lastname@example.org|
|Contact: Louis-Nicolas Veilleux, PhD +1 514 2827175 email@example.com|
|Principal Investigator: Frank Rauch, MD|
Sponsors and Collaborators
Louis-Nicolas Veilleux Ph.D.