Calcium + Vitamin D Supplementation for Low Bone Mass in Adolescent Idiopathic Scoliosis (AIS)
Primary Purpose
Scoliosis
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Calcium 600mg plus Vit D 400 IU
Calcium 600mg plus Vit D 800 IU
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Scoliosis focused on measuring Adolescent Idiopathic Scoliosis, AIS, low bone mass, osteopenia, bone health, bone density
Eligibility Criteria
Inclusion Criteria:
- Between the ages of 11-14 (Tanner stage < IV)
- Low BMD (z-score < 0 from age-matched population mean)
- Cobb's Angle greater or equal to 15°
- Presentation at the Scoliosis Clinic without prior treatment for low bone mass.
Exclusion Criteria:
- Scoliosis with any known etiology such as congenital scoliosis, neuromuscular scoliosis, scoliosis of metabolic etiology, scoliosis with skeletal dysplasia, or
- Patient with known endocrine and connective tissue abnormalities, or
- Patient with eating disorders or GI malabsorption disorders or
- Prior treatment for low bone mass before being recruited into the study.
- Patient currently taking medication that affects bone metabolism eg corticosterone or estrogen.
Sites / Locations
- Prince of Wales Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Placebo
Ca600mg+VitD400IU
Ca600mg+VitD800IU
Arm Description
Subjects in this group will take the placebo tablets
subjects receive a daily dose of 600 mg elemental calcium and 400 IU vitamin D3
subjects receive a daily dose of 600 mg elemental calcium and 800 IU vitamin D3
Outcomes
Primary Outcome Measures
Bone mineral density
To determine the effects of calcium and vitamin D intervention on improving bone mineral density of skeletally immature AIS girls with low bone mass.
Secondary Outcome Measures
Curve severity
To determine the effects of calcium and vitamin D intervention on preventing curve progression of skeletally immature AIS girls with low bone mass.
Full Information
NCT ID
NCT01103115
First Posted
April 5, 2010
Last Updated
February 2, 2015
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT01103115
Brief Title
Calcium + Vitamin D Supplementation for Low Bone Mass in Adolescent Idiopathic Scoliosis (AIS)
Official Title
Can Calcium and Vitamin D Supplementation Improve Bone Mineral Density and Curve Progression in Girls With Adolescent Idiopathic Scoliosis?
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether Calcium and Vit D supplementation is effective for improving low bone mass in Girls with Adolescent Idiopathic Scoliosis (AIS).
Detailed Description
Adolescent Idiopathic Scoliosis (AIS) is a prevalent condition mainly affecting females with disease onset at early puberty. It can lead to serious health problems and is associated with low bone mass which can persist with growth. Osteopenia is found to be an important prognostic factor for curve progression in AIS. Nutritional studies indicated AIS subjects had low dietary calcium intake. Evidences suggested that Vit D insufficiency could be present in AIS. Calcium and vitamin D supplementation can therefore be a viable treatment option for low bone mass in AIS subjects. The primary objective of this prospective randomized double-blinded placebo-controlled trial is to find out whether calcium and vitamin D supplementation can improve bone mineral density (BMD) in osteopenic AIS subjects. The secondary objective of this study is to evaluate whether the supplementation is effective in controlling curve progression in AIS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis
Keywords
Adolescent Idiopathic Scoliosis, AIS, low bone mass, osteopenia, bone health, bone density
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
330 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects in this group will take the placebo tablets
Arm Title
Ca600mg+VitD400IU
Arm Type
Active Comparator
Arm Description
subjects receive a daily dose of 600 mg elemental calcium and 400 IU vitamin D3
Arm Title
Ca600mg+VitD800IU
Arm Type
Active Comparator
Arm Description
subjects receive a daily dose of 600 mg elemental calcium and 800 IU vitamin D3
Intervention Type
Dietary Supplement
Intervention Name(s)
Calcium 600mg plus Vit D 400 IU
Intervention Description
Daily supplementation with 600mg Calcium plus 400IU Vitamin D3
Intervention Type
Dietary Supplement
Intervention Name(s)
Calcium 600mg plus Vit D 800 IU
Intervention Description
Daily supplementation with 600mg Calcium plus 800IU Vitamin D3
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
placebo tablets
Primary Outcome Measure Information:
Title
Bone mineral density
Description
To determine the effects of calcium and vitamin D intervention on improving bone mineral density of skeletally immature AIS girls with low bone mass.
Time Frame
2-year time point
Secondary Outcome Measure Information:
Title
Curve severity
Description
To determine the effects of calcium and vitamin D intervention on preventing curve progression of skeletally immature AIS girls with low bone mass.
Time Frame
2-year time point
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Between the ages of 11-14 (Tanner stage < IV)
Low BMD (z-score < 0 from age-matched population mean)
Cobb's Angle greater or equal to 15°
Presentation at the Scoliosis Clinic without prior treatment for low bone mass.
Exclusion Criteria:
Scoliosis with any known etiology such as congenital scoliosis, neuromuscular scoliosis, scoliosis of metabolic etiology, scoliosis with skeletal dysplasia, or
Patient with known endocrine and connective tissue abnormalities, or
Patient with eating disorders or GI malabsorption disorders or
Prior treatment for low bone mass before being recruited into the study.
Patient currently taking medication that affects bone metabolism eg corticosterone or estrogen.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tsz-ping Lam
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital
City
Hong Kong SAR
Country
China
12. IPD Sharing Statement
Links:
URL
http://www.ort.cuhk.edu.hk/
Description
Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong
Learn more about this trial
Calcium + Vitamin D Supplementation for Low Bone Mass in Adolescent Idiopathic Scoliosis (AIS)
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