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Vitamin A DeficiencyNCT07335991

Effect of Vitamin A Supplementation on Idiopathic Scoliosis

A study testing Vitamin A and Nutritional Education in people with Vitamin A Deficiency and Idiopathic Scoliosis, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 15 years
Conditions the study is for
Vitamin A Deficiency, Idiopathic Scoliosis
What is being tested?
Vitamin A and Nutritional Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
1 siteChina
Study dates
13 May 2025to 1 Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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:
Show all 12Show fewer
  • 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).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xiangyang Wang, MD contact

86-13506663458

Xiangyangwang@wmu.edu.com

China1 site, 1 recruiting
  • The Second Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

    Xiangyang Wang, MD, 13506663458, Xiangyangwang@wmu.edu.com

    Xiangyangwang@wmu.edu.com

    Recruiting

Other trials in China

About this study

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

Read the 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.

Being tested
Vitamin A, Nutritional Education
Medical subject headings
Vitamin A Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin ADietary supplement

    Vitamin A supplements plus Nutritional Education

  • Nutritional EducationBehavioural

    Nutritional Education Only

Study groups in NCT07335991
Study groupRoleWhat they receive
Vitamin A Supplementation plus Nutritional EducationExperimental1. 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.
Receives: Dietary Supplement: Vitamin A
Nutritional Education OnlyActive comparator1. 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.
Receives: Behavioral: Nutritional Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

  2. 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.

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

Secondary outcomes (5)
  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.

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

  2. 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.

    Measured: At baseline and months 6

  3. 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.

    Measured: At baseline and months 6

  4. 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).

    Measured: At baseline and months 6

  5. Circadian rhythm Measurements

    Circadian rhythm as assessed by Morning and Evening Questionnaire-5 (MEQ-5)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2026
  2. Study start13 May 2025
  3. Primary completion1 Jun 2028 (estimated)
  4. Study completion1 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07335991
Sponsor's protocol ID
SAHoWMU-CR2026-08-113
Status last verified
May 2026
First submitted
1 Jan 2026
Last updated
15 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Vitamin A and Nutritional Education in people with Vitamin A Deficiency and Idiopathic Scoliosis, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xiangyang Wang, MD (86-13506663458, Xiangyangwang@wmu.edu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Scoliosis Curve Angle (time frame: Routine follow-up visits will be scheduled 6 months apart up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.

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