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Recruiting NCT07335991

Effect of Vitamin A Supplementation on Idiopathic Scoliosis

No phase Interventional Vitamin A Deficiency Idiopathic Scoliosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vitamin A, Nutritional Education.
Who it may be relevant to
Registry conditions: Vitamin A Deficiency, Idiopathic Scoliosis. Basic parameters: 6 years — 15 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effect of Vitamin A Supplementation on the Onset and Progression of Idiopathic Scoliosis: A Prospective, Single-Blind, Randomized Controlled Trial

Overview

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.

Detailed description

Idiopathic scoliosis (IS) is the most common structural spinal deformity in children and adolescents. Despite extensive research, its etiology remains largely unknown, resulting in a lack of modifiable targets for prevention or early intervention. Notably, preliminary unpublished data from our pediatric health center indicate a high prevalence (up to 30%) of mild scoliosis among children with vitamin A deficiency. Furthermore, our pilot data suggest a tendency toward vitamin A insufficiency in many children diagnosed with IS. Vitamin A is critical for normal bone growth, embryonic skeletal development, and the maintenance of epithelial tissues. We hypothesize that chronic vitamin A deficiency may represent a modifiable risk factor that contributes to the pathogenesis or progression of IS by disrupting these fundamental processes.

This study will be conducted at the "Child Health-Spine Wellness" Center. Children with idiopathic scoliosis and concurrent vitamin A deficiency or insufficiency will be randomized into one of two groups. The Intervention Group will receive sustained biochemical correction through daily oral vitamin A supplementation (2000 IU) for 6 months, coupled with a standardized nutritional education session. The Control Group will receive an identical nutritional education session but no study-provided supplements, serving as an active comparator that controls for the effects of increased health awareness and general dietary advice. For all children with scoliosis, routine follow-up visits with radiographic assessment will be scheduled at 6-month intervals for at least 24 months to evaluate curve progression. Additionally, children with vitamin A deficiency but without scoliosis at baseline will also be randomized to the same supplementation regimens and will undergo annual scoliosis screening as part of an ongoing provincial health initiative. All participants will undergo serial radiographic and clinical assessments.

At the same time, a structured safety monitoring plan will be implemented to prevent and promptly identify both vitamin A deficiency persistence and hypervitaminosis A. Prior to randomization, all caregivers will receive standardized education on the signs and symptoms of both significant vitamin A deficiency (e.g., night blindness, dry eyes) and acute/chronic hypervitaminosis A (e.g., headache, nausea/vomiting, dizziness, blurred vision, skin dryness/peeling). They will be instructed to report any such symptoms immediately to the study team via a dedicated 24-hour contact line. Serum retinol concentration will be measured for all participants at baseline and the 6-month visit. This serves the dual purpose of monitoring adherence in the Long-term. If a participant's serum retinol level exceeds 1.0 mg/L, the study supplementation will be immediately suspended, and the participant will be referred to a pediatric nutritionist for further evaluation and management.

Interventions

  • Dietary supplement Vitamin A
    Vitamin A supplements plus Nutritional Education
  • Behavioral Nutritional Education
    Nutritional Education Only

Primary outcome measures

  • Scoliosis Curve Angle [Time frame: Routine follow-up visits will be scheduled 6 months apart up to 24 months]
  • Angle of Trunk Rotation [Time frame: Routine follow-up visits will be scheduled 6 months apart up to 24 months]
Secondary outcome measures (5)
  • Scoliosis Research Society-22 (SRS-22) questionnaire [Time frame: Routine follow-up visits will be scheduled 6 months apart up to 24 months]
  • Change in Serum Vitamin A (Retinol) Level [Time frame: At baseline and months 6]
  • Serum Levels of Vitamin D [Time frame: At baseline and months 6]
  • Change in Gene Expression Levels of biomarkers [Time frame: At baseline and months 6]
  • Circadian rhythm Measurements [Time frame: Routine follow-up visits will be scheduled 6 months apart up to 24 months]

Eligibility criteria

Inclusion 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.

Exclusion criteria

  • 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • The Second Affiliated Hospital of Wenzhou Medical University — Wenzhou

Identifiers

NCT: NCT07335991 · SAHoWMU-CR2026-08-113

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗