ClinicalTrialsFinder
RecruitingNot ApplicableNCT07335991

Effect of Vitamin A Supplementation on Idiopathic Scoliosis

Effect of Vitamin A Supplementation on the Onset and Progression of Idiopathic Scoliosis: A Prospective, Single-Blind, Randomized Controlled Trial

Sponsor

Second Affiliated Hospital of Wenzhou Medical University

Enrollment

140 participants

Start Date

May 13, 2025

Study Type

INTERVENTIONAL

Summary

This study aims to investigate whether vitamin A supplementation can influence spinal curve magnitude in idiopathic scoliosis children and potentially prevent its de novo development.

Eligibility

Min Age: 6 YearsMax Age: 15 Years

Inclusion Criteria5

  • Age between 6 and 15 years.
  • Biochemically confirmed vitamin A deficiency (serum retinol < 0.20 mg/L) or insufficiency (serum retinol 0.20-0.29 mg/L).
  • Has undergone radiographic evaluation (standing full-spine X-ray) for idiopathic scoliosis at the initial clinic visit.
  • Skeletally immature (Risser sign 0-3) with a major Cobb angle < 40 degrees at baseline.
  • Written informed consent/assent provided by the participant and legal guardian.

Exclusion Criteria12

  • Unwillingness or inability to comply with all study procedures and follow-up visits.
  • Plans to relocate outside the study area within the next 24 months.
  • Previous high-dose vitamin A supplementation therapy within the past 12 months.
  • Clinical signs of severe vitamin A deficiency syndrome (e.g., xerophthalmia, Bitot's spots).
  • Serum vitamin A level > 0.70 mg/L (to avoid risk of hypervitaminosis A).
  • Severe chronic health conditions that could confound study outcomes, including but not limited to:
  • Known syndromic, neuromuscular, or congenital musculoskeletal causes of scoliosis.
  • History of spine surgery or significant spinal trauma.
  • Spinal tumor.
  • Leg length discrepancy > 20 mm.
  • Other severe chronic diseases (e.g., poorly controlled diabetes, chronic liver or renal disease, malabsorption syndromes).
  • Severe obesity (body mass index z-score ≥ 3).

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIETARY_SUPPLEMENTVitamin A

Vitamin A supplements plus Nutritional Education

BEHAVIORALNutritional Education

Nutritional Education Only

Locations(1)

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07335991