๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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 โฅ 3).
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What it tests
- Vitamin A
- Nutritional Education
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.