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

NCT03533010 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 199

Last updated 2024-12-04

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Tsz Ping Lam · Chinese University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
14 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2023-12-30
Completion
2023-12-30

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03533010 on ClinicalTrials.gov