NCT03533010

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 199 (actual)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: Female
• Age: 10 Years – 14 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Scoliosis
• Spinal Curvatures
• Spinal Diseases
• Bone Health
• Vitamin D

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Ca500mg	subjects receive a daily dose of 500mg elemental calcium
DIETARY_SUPPLEMENT	VitD800IU	subjects receive a daily dose of 800IU VitD3
OTHER	Placebo	subjects receive placebo tablet

Timeline

• Start date: 2018-06-01
• Primary completion: 2023-12-30
• Completion: 2023-12-30
• First posted: 2018-05-22
• Last updated: 2024-12-04

Locations

1 site across 1 country: Hong Kong