Effect of Vitamin A Supplementation on Idiopathic Scoliosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-15
SponsorSecond Affiliated Hospital of Wenzhou Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Vitamin A
Dietary supplementVitamin A supplements plus Nutritional Education
Nutritional Education
BehavioralNutritional Education Only
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Vitamin A Supplementation plus Nutritional EducationExperimental treatment 1 intervention
Group B: Nutritional Education OnlyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Routine follow-up visits will be scheduled 6 months apart up to 24 months2
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 monthsSecondary outcomes
1
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 months2
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 63
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 64
Change in Gene Expression Levels of biomarkers
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 6Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Second Affiliated Hospital of Wenzhou Medical University
Lead sponsor
The Children's Hospital of Zhejiang University School of Medicine
Collaborator
Ningbo No. 1 Hospital
Collaborator
Ningbo No.2 Hospital
Collaborator
The Third Affiliated Hospital of Wenzhou Medical University
Collaborator
Source ClinicalTrials.gov