Vitamin A supplementation for children with idiopathic scoliosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Xiangyang Wang, MD
• Email: Xiangyangwang@wmu.edu.com
• Phone: 86-13506663458

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.