Effect of Vitamin A Supplementation on Idiopathic Scoliosis

NCT07335991 | Recruiting DMC

• 1 other identifier: SAHoWMU-CR2026-08-113
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vitamin A Deficiency; Idiopathic Scoliosis

Outcome Measures

Primary Outcomes (2)

• Scoliosis 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

  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.

  Routine follow-up visits will be scheduled 6 months apart up to 24 months

Secondary Outcomes (5)

• 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

Study Arms (2)

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.

Dietary Supplement: Vitamin A

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.

Behavioral: Nutritional Education

Interventions

Vitamin A DIETARY_SUPPLEMENT

Vitamin A supplements plus Nutritional Education

Vitamin A Supplementation plus Nutritional Education

Nutritional Education BEHAVIORAL

Nutritional Education Only

Nutritional Education Only

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify 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 may not qualify 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:
• 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).

Sponsors & Collaborators

• Ningbo No. 1 Hospital: collaborator
• Second Affiliated Hospital of Wenzhou Medical University: lead
• The Children's Hospital of Zhejiang University School of Medicine: collaborator
• Ningbo No.2 Hospital: collaborator
• The Third Affiliated Hospital of Wenzhou Medical University: collaborator

Study Sites (1)

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

RECRUITING

MeSH Terms

Conditions

Vitamin A Deficiency

Interventions

Vitamin A

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Central Study Contacts

Xiangyang Wang, MD

CONTACT

86-13506663458; Xiangyangwang@wmu.edu.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The radiologists measuring Cobb angles will be blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Chief physician, Doctorial superviso

Study Record Dates

• First Submitted: January 1, 2026
• First Posted: January 13, 2026
• Study Start: May 13, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 15, 2026

Record last verified: 2026-05

Locations

CN (1)