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New treatment option for Vitamin A Deficiency
Official title Effect of Vitamin A Supplementation on Idiopathic Scoliosis
ClinicalTrials.gov ID: NCT07335991
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 15
You may be able to join if
- 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.
You likely can't join if
- 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:
See the full eligibility criteria
- 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.
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Wenzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 15 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wenzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.