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

Not Applicable

Completed

• Conditions: Spinal Diseases; Bone Health; Vitamin D; Scoliosis; Spinal Curvatures
• Interventions: Dietary Supplement: Ca500mg; Other: Placebo; Dietary Supplement: VitD800IU

• Registration Number: NCT03533010
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-04-30
• Study First Submitted QC: 2018-05-10
• Study First Posted: 2018-05-22
• Study Start: 2018-06-01
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 199

Inclusion Criteria

1. girls with diagnosis of AIS confirmed after detailed clinical and radiological assessment and
2. between 10 to 14 years old and
3. Risser between 0 to 2 and
4. pre-menarche or < 1 year post-menarche and
5. Cobb angle between 10° to 20 ° and
6. no prior bracing or other treatment for scoliosis and
7. no prior treatment for bone health

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Exclusion Criteria

1. scoliosis with any known etiology such as congenital scoliosis, neuromuscular scoliosis, scoliosis of metabolic etiology, scoliosis with skeletal dysplasia or

2. patients with known endocrine and connective tissue abnormalities, or

3. patients with eating disorders or gastrointestinal malabsorption disorders or any disorders that are known to affect calcium or bone metabolism or

4. prior treatment for bone health before being recruited into the study or

5. patient currently taking medication that affects bone metabolism eg steroid or

6. patient with contra-indications for calcium and Vit-D supplementation:

   1. history of hypersensitivity to the active or placebo tablets
   2. history of renal diseases and renal calculi (nephrolithiasis)
   3. diseases and/or conditions resulting in hypercalcaemia and/or hypercalciuria
   4. hypervitaminosis D

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ca500mg + VitD800IU	VitD800IU	Daily Supplementation with 500mg Calcium plus 800IU Vitamin D3
Ca500mg + VitD800IU	Ca500mg	Daily Supplementation with 500mg Calcium plus 800IU Vitamin D3
Placebo	Placebo	Dietary Supplement: Placebo

Primary Outcome Measures

Name	Time	Method
Curve progression (Cobb)	3 years	Percentage of patients with increase in Cobb angle ≥ 6 degrees
Curve progression (Bracing)	3 years	Percentage of patients who require bracing

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Orthopaedics and Traumatology, Prince of Wales Hospital; 🇭🇰 Hong Kong, Hong Kong