Calcium + Vitamin D Supplementation for Low Bone Mass in Adolescent Idiopathic Scoliosis (AIS)

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Can Calcium and Vitamin D Supplementation Improve Bone Mineral Density and Curve Progression in Girls With Adolescent Idiopathic Scoliosis?

Conditions
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Scoliosis

Intervention / Treatment
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* Dietary Supplement: Calcium 600mg plus Vit D 400 IU
* Dietary Supplement: Calcium 600mg plus Vit D 800 IU
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Subjects in this group will take the placebo tablets | Dietary Supplement: Placebo<br>* placebo tablets<br>|
| Active Comparator: Ca600mg+VitD400IU<br>subjects receive a daily dose of 600 mg elemental calcium and 400 IU vitamin D3 | Dietary Supplement: Calcium 600mg plus Vit D 400 IU<br>* Daily supplementation with 600mg Calcium plus 400IU Vitamin D3<br>|
| Active Comparator: Ca600mg+VitD800IU<br>subjects receive a daily dose of 600 mg elemental calcium and 800 IU vitamin D3 | Dietary Supplement: Calcium 600mg plus Vit D 800 IU<br>* Daily supplementation with 600mg Calcium plus 800IU Vitamin D3<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescent Idiopathic Scoliosis, AIS, low bone mass, osteopenia, bone health, bone density