Clinical Trials in China / NCT07335991
Recruiting
Not applicable
Effect of Vitamin A Supplementation on Idiopathic Scoliosis
NCT07335991 · tracked via the Priya Life Science China tracker
Condition(s) studied
Vitamin A DeficiencyIdiopathic Scoliosis
Investigational drug(s) / intervention(s)
Vitamin ANutritional Education
Vitamin A: Vitamin A supplements plus Nutritional Education
Nutritional Education: Nutritional Education Only
Study 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
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).
Primary outcome measure(s)
- Scoliosis Curve Angle — Routine follow-up visits will be scheduled 6 months apart up to 24 months
A long standard standing whole spine radiograph will be used for measuring curve size in terms of Cobb angle according to the standard Cobb method - Angle of Trunk Rotation — Routine follow-up visits will be scheduled 6 months apart up to 24 months
In addition to spinal X-rays, a Scoliometer can also help monitor curve progression. The Scoliometer is an inclinometer that measures the asymmetries between the sides of the trunk by measuring axial rotation in degrees. Numerous studies have found a high correlation between trunk axial rotation (ATR) values and the Cobb angles.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| The Second Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | Recruiting |
More Second Affiliated Hospital of Wenzhou Medical University trials in China
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07335991 on ClinicalTrials.gov ↗ ← All trials in China