ClinicalTrials.gg
Status unknownNCT04127968Updated Jan 4, 2022

Efficacy and Safety of Vitamin A Treatment for Children With Sepsis

An interventional study of Vitamin A and Oil in Vitamin A Deficiency, Pediatric and Sepsis, sponsored by West China Hospital. Status unknown. Open to participants aged 0 Months to 192 Months. Per ClinicalTrials.gov, last updated 2022-01-04.

Sponsored by West China Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
450
Allocation
Randomized
Ages
0 Months to 192 Months
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 10 studies testing Vitamin A in Vitamin A Deficiency — 2 open to participants now, 2 under way, none of them phase 3. Vitamin A · Vitamin A Deficiency.

Planned enrollment
4th of 10
450 · median 350
Started
2022
the only one that year
No phase
4 of 10
1 open now
Registered
8th of 10
by date
Lead sponsor
1 of 10
West China Hospital

Among the 10 studies testing Vitamin A in Vitamin A Deficiency, this one is the 4th largest by planned enrollment, is the only one that started in 2022, is one of 4 with no phase, and was the 8th registered.

Vitamin A Deficiency

67 studies on the registry are indexed under Vitamin A Deficiency; 7 are open to participants now.

Browse Vitamin A Deficiency studies →

Open to participants now

2 of the 10 studies testing Vitamin A in Vitamin A Deficiency are open now, in 2 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 2 open studies →

About Vitamin A

Vitamin A: first FDA approval 1953 (M.V.I.-12 ADULT). What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 6 Vitamin A Deficiency studies recruiting now, 3 set no upper age limit and 3 stop at 75 or younger; 2 take children under 18; 2 take healthy volunteers.

This study: 0 Months to 192 Months · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 10 studies testing Vitamin A in Vitamin A Deficiency, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Vitamin A Deficiency
  • Pediatric
  • Sepsis
04

Who can participate

Ages eligible
0 Months to 192 Months
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. age \< 18 years,
  2. Expected to stay in the ICU for 48 hours or more,
  3. Vitamin A deficiency (VA \< 0.2 mg/L)

Exclusion criteria

Exclusion Criteria:

  1. Severely impaired gastrointestinal function
  2. Premature infants and low birth weight (LBW) infants
  3. Condition of underlying organ dysfunction
  4. Having received chemotherapy or radiotherapy
  5. Hematological
  6. Primary or acquired immunodeficiency
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
450 participants (estimated)

Study arms

  • Experimental
    intervention group

    Septic children with vitamin A deficiency who will receive vitamin A supplementation.

    Drug: Vitamin A

  • Placebo comparator
    control group

    Septic children with vitamin A deficiency who will receive placebo.

    Drug: Oil

Interventions

  • Children in intervention group will receive 50,000 IU vitamin A after being randomized.

  • DrugOil

    Children in control group will receive equal volume of oil.

06

What researchers measure

Primary outcomes

  1. length of hospital stay

    The length of hospital stay will be measured by days

    Time frame: 2 years

Secondary outcomes

  1. hospital mortality

    Hospital mortality will be record as ratio

    Time frame: 2 years

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2022; primary completion for Dec 2023, 13 months later.

Of 19 interventional studies with no phase under Vitamin A Deficiency, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 26. This study's planned 13 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 12, 2019
First posted
Oct 16, 2019
StartEst.
Nov 1, 2022
Primary completionEst.
Dec 31, 2023
CompletionEst.
May 31, 2024
Last update
Jan 4, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04127968
Responsible party
Yi Ji (MD, PhD, West China Hospital) — Principal investigator
First posted
Oct 16, 2019
Start date
Nov 1, 2022 (estimated)
Primary completion
Dec 31, 2023 (estimated)
Completion
May 31, 2024 (estimated)
Last update
Jan 4, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Vitamin A

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