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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2024
  • participants needed
    500
  • sponsor
    Chinese University of Hong Kong
Updated on 5 February 2021

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 angle6 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.

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 angle6 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.

Details
Condition Vitamin D, Ergocalciferol, Scoliosis, Curvature of spine, Spondylopathy, Bone Diseases, Bone Diseases, Bone Health, spinal diseases, spine disorders, spinal disease, spine disorder, vit d, d vitamin, vitamin-d
Treatment Placebo, Ca500mg, VitD800IU
Clinical Study IdentifierNCT03533010
SponsorChinese University of Hong Kong
Last Modified on5 February 2021

Eligibility

Yes No Not Sure

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
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