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临床试验/NCT07335991
NCT07335991招募中不适用

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

Second Affiliated Hospital of Wenzhou Medical University1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2025年5月13日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
140
试验地点
1
主要终点
Scoliosis Curve Angle

研究概览

简要总结

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.

详细描述

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 Notably, preliminary unpublished data from our pediatric health center indicate a high prevalence (up to 30%) of mild scoliosis among children with vitamin A deficiency.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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

The radiologists measuring Cobb angles will be blinded to treatment allocation.

入排标准

年龄范围
6 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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).

研究组 & 干预措施

Nutritional Education Only

Active Comparator
  1. Behavioral: Nutritional Education: An identical one-time, standardized educational session and materials as provided to Arm 1.
  2. No study-provided vitamin A supplements will be administered.

干预措施: Nutritional Education (Behavioral)

Vitamin A Supplementation plus Nutritional Education

Experimental
  1. Dietary Supplement: A daily oral dose of 2000 IU Vitamin A (as retinyl palmitate or acetate) for 6 consecutive months.
  2. Behavioral: Nutritional Education: A one-time, standardized educational session at baseline delivered by a study dietitian. The session covers principles of a balanced diet for bone health, with a focus on food sources rich in vitamin A.

干预措施: Vitamin A (Dietary Supplement)

结局指标

主要结局

Scoliosis Curve Angle

时间窗: 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

时间窗: 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.

次要结局

  • Scoliosis Research Society-22 (SRS-22) questionnaire(Routine follow-up visits will be scheduled 6 months apart up to 24 months)
  • Change in Serum Vitamin A (Retinol) Level(At baseline and months 6)
  • Serum Levels of Vitamin D(At baseline and months 6)
  • Change in Gene Expression Levels of biomarkers(At baseline and months 6)
  • Circadian rhythm Measurements(Routine follow-up visits will be scheduled 6 months apart up to 24 months)

研究者

发起方
Second Affiliated Hospital of Wenzhou Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiangyang Wang

M.D., Chief physician, Doctorial superviso

Second Affiliated Hospital of Wenzhou Medical University

研究点 (1)

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