Calcium + Vitamin D Supplementation for Low Bone Mass in Adolescent Idiopathic Scoliosis (AIS)
This study has been completed.
Sponsor:
Chinese University of Hong Kong
Information provided by (Responsible Party):
CHENG Chun-yiu Jack, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01103115
First received: April 5, 2010
Last updated: February 2, 2015
Last verified: February 2015
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Scoliosis |
Dietary Supplement: Calcium 600mg plus Vit D 400 IU Dietary Supplement: Calcium 600mg plus Vit D 800 IU Dietary Supplement: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Can Calcium and Vitamin D Supplementation Improve Bone Mineral Density and Curve Progression in Girls With Adolescent Idiopathic Scoliosis? |
Resource links provided by NLM:
Further study details as provided by Chinese University of Hong Kong:
Primary Outcome Measures:
- Bone mineral density [ Time Frame: 2-year time point ] [ Designated as safety issue: No ]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 [ Time Frame: 2-year time point ] [ Designated as safety issue: No ]To determine the effects of calcium and vitamin D intervention on preventing curve progression of skeletally immature AIS girls with low bone mass.
| Enrollment: | 330 |
| Study Start Date: | April 2010 |
| Study Completion Date: | February 2015 |
| Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
Subjects in this group will take the placebo tablets
|
Dietary Supplement: Placebo
placebo tablets
|
|
Active Comparator: Ca600mg+VitD400IU
subjects receive a daily dose of 600 mg elemental calcium and 400 IU vitamin D3
|
Dietary Supplement: Calcium 600mg plus Vit D 400 IU
Daily supplementation with 600mg Calcium plus 400IU Vitamin D3
|
|
Active Comparator: Ca600mg+VitD800IU
subjects receive a daily dose of 600 mg elemental calcium and 800 IU vitamin D3
|
Dietary Supplement: Calcium 600mg plus Vit D 800 IU
Daily supplementation with 600mg Calcium plus 800IU Vitamin D3
|
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.
Eligibility| Ages Eligible for Study: | 11 Years to 14 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01103115
Please refer to this study by its ClinicalTrials.gov identifier: NCT01103115
Locations
| China | |
| Prince of Wales Hospital | |
| Hong Kong SAR, China | |
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
| Principal Investigator: | Tsz-ping Lam | Chinese University of Hong Kong |
More Information
Additional Information:
No publications provided
| Responsible Party: | CHENG Chun-yiu Jack, Professor, Chinese University of Hong Kong |
| ClinicalTrials.gov Identifier: | NCT01103115 History of Changes |
| Other Study ID Numbers: | AIS_Ca_VitD_01 |
| Study First Received: | April 5, 2010 |
| Last Updated: | February 2, 2015 |
| Health Authority: | Hong Kong: Department of Health China: The Government of the Hong Kong Special Administrative Region of the People's Republic of China |
Keywords provided by Chinese University of Hong Kong:
|
Adolescent Idiopathic Scoliosis AIS low bone mass |
osteopenia bone health bone density |
Additional relevant MeSH terms:
|
Scoliosis Bone Diseases Musculoskeletal Diseases Spinal Curvatures Spinal Diseases Calcium Carbonate Calcium, Dietary Ergocalciferols Vitamin D |
Vitamins Antacids Bone Density Conservation Agents Growth Substances Micronutrients Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on March 03, 2015