Vitamin A DeficiencyNCT04127968
Efficacy and Safety of Vitamin A Treatment for Children With Sepsis
A study testing Vitamin A and Oil in people with Vitamin A Deficiency and Pediatric, run by West China Hospital.
Trial summary
The prevalence of vitamin A deficiency was found high in children with sepsis. Whether those patients will benefit from the vitamin A supplementation is unknown. Read more about this study
- Who is it for?
- Ages 0 to 192 months
- Conditions the study is for
- Vitamin A Deficiency, Pediatric, Sepsis
- What is being tested?
- Vitamin A and Oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2022to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 0 to 192 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age < 18 years,
- Expected to stay in the ICU for 48 hours or more,
- Vitamin A deficiency (VA < 0.2 mg/L)
Who cannot join
- Severely impaired gastrointestinal function
- Premature infants and low birth weight (LBW) infants
- Condition of underlying organ dysfunction
- Having received chemotherapy or radiotherapy
- Hematological malignancies
- Primary or acquired immunodeficiency
About this study
Official title: Efficacy and Safety of Vitamin A Treatment for Children With Sepsis: a Randomized Placebo-controlled Clinical Trial
The prevalence of vitamin A deficiency was found high in children with sepsis. Whether those patients will benefit from the vitamin A supplementation is unknown.
Read the detailed description
It was reported that the prevalence of vitamin A deficiency was highly as 58% in critically ill children with sepsis. However, whether those patients will benefit from the vitamin A supplementation is unknown. We design an randomized, double-blind, placebo-controlled, multi-center trial to investigate the effect of vitamin A supplementation on the outcome of critically ill children with sepsis.
- Conditions
- Vitamin A Deficiency, Pediatric, Sepsis
- Being tested
- Vitamin A, Oil
- Medical subject headings
- Vitamin A Deficiency, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin ADrug
Children in intervention group will receive 50,000 IU vitamin A after being randomized.
OilDrug
Children in control group will receive equal volume of oil.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Septic children with vitamin A deficiency who will receive vitamin A supplementation. Receives: Drug: Vitamin A |
| control group | Placebo comparator | Septic children with vitamin A deficiency who will receive placebo. Receives: Drug: Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of hospital stay
The length of hospital stay will be measured by days
Measured: 2 years
Secondary outcomes (1)
hospital mortality
Hospital mortality will be record as ratio
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start1 Nov 2022 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin A DeficiencyStudies of the same condition, open and under way.
- More trials run by West China HospitalThe 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Ji, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04127968
- Sponsor's protocol ID
- 1010
- Status last verified
- Jan 2022
- First submitted
- 12 Oct 2019
- Last updated
- 4 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fu Q, Liu M, Zhang X, Fu J, Zhang G, Ji Y, Chen S. A randomized controlled trial on the efficacy and safety of vitamin A supplementation in children with sepsis. Front Pediatr. 2025 Aug 6;13:1579006. doi: 10.3389/fped.2025.1579006. eCollection 2025.
PubMed 40843069
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Vitamin A Treatment for Children With Sepsis: a Randomized Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04127968
- Acronym / sponsor ID
- 1010
- Conditions
- Vitamin A Deficiency, Pediatric, Sepsis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 16 Oct 2019 (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.
The prevalence of vitamin A deficiency was found high in children with sepsis. Whether those patients will benefit from the vitamin A supplementation is unknown.
Detailed description
It was reported that the prevalence of vitamin A deficiency was highly as 58% in critically ill children with sepsis. However, whether those patients will benefit from the vitamin A supplementation is unknown. We design an randomized, double-blind, placebo-controlled, multi-center trial to investigate the effect of vitamin A supplementation on the outcome of critically ill children with sepsis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Drug: Vitamin ASeptic children with vitamin A deficiency who will receive vitamin A supplementation. |
| control group | Placebo comparator | Drug: OilSeptic children with vitamin A deficiency who will receive placebo. |
Who may qualify
- Ages
- 0 to 192 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- age < 18 years,
- Expected to stay in the ICU for 48 hours or more,
- Vitamin A deficiency (VA < 0.2 mg/L)
Key exclusion criteria (6 listed)
- Severely impaired gastrointestinal function
- Premature infants and low birth weight (LBW) infants
- Condition of underlying organ dysfunction
- Having received chemotherapy or radiotherapy
- Hematological malignancies
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 AChildren in intervention group will receive 50,000 IU vitamin A after being randomized. | Drug | intervention group |
| OilChildren in control group will receive equal volume of oil. | Drug | control group |
Primary outcome
length of hospital stay
Time frame: 2 years
The length of hospital stay will be measured by days
1 secondary outcome
hospital mortality
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Derived from this study: PubMed 40843069Fu Q, Liu M, Zhang X, Fu J, Zhang G, Ji Y, Chen S. A randomized controlled trial on the efficacy and safety of vitamin A supplementation in children with sepsis. Front Pediatr. 2025 Aug 6;13:1579006. doi: 10.3389/fped.2025.1579006. eCollection 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin A and Oil in people with Vitamin A Deficiency and Pediatric, run by West China Hospital.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
length of hospital stay (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04127968, which also lists 1 linked publication.
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 4 Jan 2022.