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.
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 Notably, preliminary unpublished data from our pediatric health center indicate a high prevalence (up to 30%) of mild scoliosis among children with vitamin A deficiency.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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
140
Vitamin A supplements plus Nutritional Education
Nutritional Education Only
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
RECRUITINGScoliosis Curve Angle
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
Time frame: Routine follow-up visits will be scheduled 6 months apart up to 24 months
Angle of Trunk Rotation
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.
Time frame: Routine follow-up visits will be scheduled 6 months apart up to 24 months
Scoliosis Research Society-22 (SRS-22) questionnaire
The SRS-22 aims to evaluate health-related quality of life (HRQOL) in patients with idiopathic scoliosis. The SRS-22 specifically addresses areas affected by spinal deformities-such as pain, self-perception, function, mental health, and satisfaction with treatment. Consequently, it offers a focused approach to understanding the patient experience.
Time frame: Routine follow-up visits will be scheduled 6 months apart up to 24 months
Change in Serum Vitamin A (Retinol) Level
Change in serum concentration of retinol (mg/L) measured by high-performance liquid chromatography (HPLC) between baseline and the 6-month visit.
Time frame: At baseline and months 6
Serum Levels of Vitamin D
Change in serum concentrations of Vitamin D potentially interacting with vitamin A metabolism or bone health from baseline to 6 months.
Time frame: At baseline and months 6
Change in Gene Expression Levels of biomarkers
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Change in mRNA expression levels of specific Genes such as HIF1A, Bmal1 and IGFBPs in peripheral blood mononuclear cells (PBMCs) as measured by quantitative reverse transcription polymerase chain reaction (qRT-PCR).
Time frame: At baseline and months 6
Circadian rhythm Measurements
Circadian rhythm as assessed by Morning and Evening Questionnaire-5 (MEQ-5)
Time frame: Routine follow-up visits will be scheduled 6 months apart up to 24 months