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.
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
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- 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.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Xiangyang Wang, MD, 13506663458, Xiangyangwang@wmu.edu.com
Xiangyangwang@wmu.edu.com
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.
- Conditions
- Vitamin A Deficiency, Idiopathic Scoliosis
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Nutritional Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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)
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
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
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
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
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.
- First posted13 Jan 2026
- Study start13 May 2025
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin A DeficiencyStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The Children's Hospital of Zhejiang University School of Medicine, Ningbo No. 1 Hospital, Ningbo No.2 Hospital, The Third Affiliated Hospital of Wenzhou Medical University
- Responsible party
- Principal investigator, Xiangyang Wang, Second Affiliated Hospital of Wenzhou Medical University
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
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin A Supplementation on the Onset and Progression of Idiopathic Scoliosis: A Prospective, Single-Blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07335991
- Acronym / sponsor ID
- SAHoWMU-CR2026-08-113
- Conditions
- Vitamin A Deficiency, Idiopathic Scoliosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Collaborators
- The Children's Hospital of Zhejiang University School of Medicine, Ningbo No. 1 Hospital, Ningbo No.2 Hospital, The Third Affiliated Hospital of Wenzhou Medical University
- Study start
- 13 May 2025 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin A Supplementation plus Nutritional Education | Experimental | Dietary Supplement: Vitamin A1. 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. |
| Nutritional Education Only | Active comparator | Behavioral: Nutritional Education1. 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. |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin AVitamin A supplements plus Nutritional Education | Dietary supplement | Vitamin A Supplementation plus Nutritional Education |
| Nutritional EducationNutritional Education Only | Behavioural | Nutritional Education Only |
Primary outcome
Scoliosis Curve Angle
Time frame: 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
Time frame: 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.
5 secondary outcomes
Scoliosis Research Society-22 (SRS-22) questionnaire
Time frame: Routine follow-up visits will be scheduled 6 months apart up to 24 months
Change in Serum Vitamin A (Retinol) Level
Time frame: At baseline and months 6
Serum Levels of Vitamin D
Time frame: At baseline and months 6
Change in Gene Expression Levels of biomarkers
Time frame: At baseline and months 6
Circadian rhythm Measurements
Time frame: Routine follow-up visits will be scheduled 6 months apart up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Vitamin A Deficiency
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Recruiting
Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS), Vitamin D Deficiency
Not yet recruiting
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
Iron Deficiency Anemia
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.