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

Conditions

Vitamin A deficiency Idiopathic Scoliosis

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).