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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Subjects in this group will take the placebo tablets |
|
| Ca600mg+VitD400IU | Active Comparator | subjects receive a daily dose of 600 mg elemental calcium and 400 IU vitamin D3 |
|
| Ca600mg+VitD800IU | Active Comparator | subjects receive a daily dose of 600 mg elemental calcium and 800 IU vitamin D3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcium 600mg plus Vit D 400 IU | Dietary Supplement | Daily supplementation with 600mg Calcium plus 400IU Vitamin D3 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2-year time point |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2-year time point |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tsz-ping Lam | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital | Hong Kong SAR | China |
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| Label | URL |
|---|---|
| Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong | View source |
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| ID | Term |
|---|---|
| D012600 | Scoliosis |
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D002118 | Calcium |
| ID | Term |
|---|---|
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
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| Calcium 600mg plus Vit D 800 IU | Dietary Supplement | Daily supplementation with 600mg Calcium plus 800IU Vitamin D3 |
|
| Placebo | Dietary Supplement | placebo tablets |
|
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001779 |
| Blood Coagulation Factors |
| D001685 | Biological Factors |