Vitamin A supplementation for children with idiopathic scoliosis

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

This test gives daily vitamin A to children with idiopathic scoliosis who have low vitamin A to see if it reduces curve size or prevents new curves.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 6 Years to 15 Years
• Sex: All
• Sponsor: Second Affiliated Hospital of Wenzhou Medical University (Academic / other)
• Locations: 1 site (Wenzhou, Zhejiang)
• Trial ID: NCT07335991 on ClinicalTrials.gov

What this trial studies

Children aged 6–15 with idiopathic scoliosis and biochemical vitamin A deficiency or insufficiency are randomized at a pediatric spine center to receive either daily oral vitamin A (2000 IU) for six months plus a standardized nutritional education session or the same education session alone. Participants are skeletally immature (Risser 0–3) with major Cobb angles under 40° at baseline and undergo standing full-spine X-rays at baseline and follow-up to measure curve magnitude and new curve development. The intervention aims for sustained biochemical correction of vitamin A levels while controlling for the effects of health education. Safety exclusions include prior high-dose vitamin A, signs of severe deficiency, or serum retinol above 0.70 mg/L to avoid hypervitaminosis A.

Who should consider this trial

Good fit: Ideal candidates are children 6–15 years old with idiopathic scoliosis, biochemical vitamin A deficiency or insufficiency, Risser 0–3, and a major Cobb angle less than 40° who can attend clinic visits and X-rays.

Not a fit: Children without low vitamin A, with advanced skeletal maturity, very large curves (≥40°), or with severe comorbid conditions are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, correcting vitamin A insufficiency could slow curve progression or reduce the likelihood of new scoliosis in susceptible children.

How similar studies have performed: This approach is largely novel for idiopathic scoliosis, with only preliminary unpublished and small pilot data suggesting an association between low vitamin A and scoliosis risk.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Unwillingness or inability to comply with all study procedures and follow-up visits.
2. Plans to relocate outside the study area within the next 24 months.
3. Previous high-dose vitamin A supplementation therapy within the past 12 months.
4. Clinical signs of severe vitamin A deficiency syndrome (e.g., xerophthalmia, Bitot's spots).
5. Serum vitamin A level \> 0.70 mg/L (to avoid risk of hypervitaminosis A).
6. 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).

Where this trial is running

Wenzhou, Zhejiang

• The Second Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Xiangyang Wang, MD

Conditions Vitamin A Deficiency; Idiopathic Scoliosis