Actively Recruiting
Effect of Vitamin A Supplementation on the Onset and Progression of Idiopathic Scoliosis: A Prospective, Single-Blind, Randomized Controlled Trial
Led by Second Affiliated Hospital of Wenzhou Medical University · Updated on 2026-05-15
140
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Second Affiliated Hospital of Wenzhou Medical University
Lead Sponsor
T
The Children's Hospital of Zhejiang University School of Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
Idiopathic scoliosis is a common spinal deformity in children and adolescents, with unclear causes that limit prevention options. This research aims to explore if vitamin A supplementation can affect spinal curve size in children with idiopathic scoliosis or help prevent new cases. Preliminary data suggest many children with scoliosis may have vitamin A deficiency or insufficiency, which is important for bone growth and tissue health. Children aged 6 to 15 with vitamin A deficiency or insufficiency and idiopathic scoliosis will be randomly assigned to two groups. The first group receives daily oral vitamin A supplements (2000 IU) for six months plus a one-time nutritional education session. The second group receives only the nutritional education session without supplements. Regular follow-ups with spine X-rays will be done every six months for at least two years to monitor scoliosis progression. Children without scoliosis but with vitamin A deficiency will also be monitored annually. Participants will have blood tests to measure vitamin A levels at the start and after six months to check treatment adherence and safety. Caregivers will be educated about symptoms of vitamin A deficiency and excess, with a 24-hour contact available for reporting concerns. If vitamin A levels become too high, supplementation will stop, and children will be referred for further care. The study measures spine curve angles, trunk rotation, vitamin levels, gene expression, quality of life, and daily rhythm patterns during follow-up visits.
CONDITIONS
Brief Title
Effect of Vitamin A Supplementation on Idiopathic Scoliosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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)
- Underwent standing full-spine X-ray evaluation for idiopathic scoliosis at initial visit
- Skeletally immature with Risser sign 0-3 and major Cobb angle less than 40 degrees at baseline
- Written informed consent/assent from participant and legal guardian
You will not qualify if you...
- Unwilling or unable to follow all study procedures and attend follow-up visits
- Plans to move outside the study area within 24 months
- High-dose vitamin A supplementation within the past 12 months
- Signs of severe vitamin A deficiency syndrome (e.g., xerophthalmia, Bitot's spots)
- Serum vitamin A level above 0.70 mg/L to avoid hypervitaminosis A risk
- Severe chronic conditions affecting study outcomes, including known syndromic, neuromuscular, or congenital scoliosis causes
- History of spine surgery or major spinal injury
- Spinal tumor
- Leg length difference greater than 20 mm
- Other severe diseases like poorly controlled diabetes, liver or kidney disease, malabsorption, or severe obesity (BMI z-score ≥ 3)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive daily oral vitamin A supplementation for 6 months along with a one-time nutritional education session, or receive nutritional education only without supplements.
1 baseline visit and 1 visit at 6 months for serum retinol measurement
Duration - Up to 24 months
Participants undergo routine follow-up visits with radiographic and clinical assessments to monitor scoliosis curve progression and other health measures.
Visits every 6 months for up to 24 months
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
Research Team
X
Xiangyang Wang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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