Preventing Curve Progression and the Need for Bracing in Adolescent Idiopathic Scoliosis With Calcium + Vitamin D Supplementation

Study Overview
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Brief Summary
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There is an association between adolescent idiopathic scoliosis (AIS) and low bone mass which has been reported to be a significant prognostic factor for curve progression. Given that dietary calcium (Ca) intake and serum Vit-D levels were also low in AIS, we therefore propose a randomized double-blinded placebo-controlled trial to evaluate if daily [500mg Ca + 800 IU Vit-D] can improve bone health and prevent curve progression in AIS. Immature AIS girls with Cobb angle 10-20 degrees will be randomized either to the Treatment or Placebo group with 3-year of treatment. The main outcome measures for evaluation for those who have completed the 3-year treatment and have reached skeletal maturity at the end of 3-year treatment include: (1) percentage of patients with increase in Cobb angle≥6 degrees and (2) percentage of patients who require bracing. Bone measurements using advanced image acquisition technology(HR-pQCT) to assess bone health will also be evaluated.

Detailed Description
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This study investigates if calcium (Ca) plus Vitamin D (Vit-D) supplementation can prevent curve progression and improve bone health in early Adolescent Idiopathic Scoliosis (AIS) during pubertal growth. AIS is a prevalent three-dimensional spinal deformity mainly affecting girls at puberty. It can lead to serious complications including spine degeneration, cardiopulmonary compromise, grossly deformed torso and psychosocial disorders. Current treatments are far from being satisfactory, with bracing being lengthy and physically demanding and surgery being a major invasive procedure. There is an association between AIS and low bone mass which has been reported to be a significant prognostic factor for curve progression. Given that dietary calcium intake and serum Vit-D levels were also low in AIS, we therefore propose a randomized double-blinded placebo-controlled trial to evaluate if daily [500mg Ca + 800 IU Vit-D] can improve bone health and prevent curve progression. Immature AIS girls with Cobb angle 10-20 degrees will be randomized either to the Treatment or Placebo group with 3-year of treatment. The main outcome measures for evaluation for those who have completed the 3-year treatment and have reached skeletal maturity at the end of 3-year treatment include: (1) percentage of patients with increase in Cobb angle≥6 degrees and (2) percentage of patients who require bracing. Bone measurements using advanced image acquisition technology (HR-pQCT) to assess bone health will also be evaluated.

Official Title
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Preventing Curve Progression and the Need for Bracing in Early Diagnosed Adolescent Idiopathic Scoliosis Using Calcium Plus Vitamin D Supplementation - A Randomized Double-blinded Placebo-controlled Trial

Conditions
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Bone Health, Scoliosis, Spinal Curvatures, Spinal Diseases, Vitamin D

Intervention / Treatment
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* Dietary Supplement: Ca500mg
* Dietary Supplement: VitD800IU
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: girls with diagnosis of AIS confirmed after detailed clinical and radiological assessment and between 10 to 14 years old and Risser between 0 to 2 and pre-menarche or < 1 year post-menarche and Cobb angle between 10° to 20 ° and no prior bracing or other treatment for scoliosis and no prior treatment for bone health Exclusion Criteria: scoliosis with any known etiology such as congenital scoliosis, neuromuscular scoliosis, scoliosis of metabolic etiology, scoliosis with skeletal dysplasia or patients with known endocrine and connective tissue abnormalities, or patients with eating disorders or gastrointestinal malabsorption disorders or any disorders that are known to affect calcium or bone metabolism or prior treatment for bone health before being recruited into the study or patient currently taking medication that affects bone metabolism eg steroid or patient with contra-indications for calcium and Vit-D supplementation: history of hypersensitivity to the active or placebo tablets history of renal diseases and renal calculi (nephrolithiasis) diseases and/or conditions resulting in hypercalcaemia and/or hypercalciuria hypervitaminosis D

Ages Eligible for Study
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Minimum Age: 10 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 |
| --- | --- |
| Active Comparator: Ca500mg + VitD800IU<br>Daily Supplementation with 500mg Calcium plus 800IU Vitamin D3 | Dietary Supplement: Ca500mg<br>* subjects receive a daily dose of 500mg elemental calcium<br>* Other names: Calcium 500mg;Dietary Supplement: VitD800IU<br>* subjects receive a daily dose of 800IU VitD3<br>* Other names: Vitamin D3 800IU;|
| Placebo Comparator: Placebo<br>Dietary Supplement: Placebo | Other: Placebo<br>* subjects receive placebo tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Curve progression (Cobb) | Percentage of patients with increase in Cobb angle ≥ 6 degrees | 3 years | 
| Curve progression (Bracing) | Percentage of patients who require bracing | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone health (BMD) | Improvement in areal bone mineral density measured with Dual-energy X-ray absorptiometry | 3 years | 
| Bone health (bone quality) | Improvement in bone quality measured with High-resolution peripheral quantitative computed tomography | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescent Idiopathic Scoliosis, Bone Health, Treatment, Vitamin D, Calcium