SepsisPhase 3NCT00707785
Effect of Vitamin A in the Treatment of Neonatal Sepsis and Necrotizing Enterocolitis
A Phase 3 study testing Vitamin A in people with Sepsis and Necrotizing Enterocolitis, run by Johns Hopkins University at 1 site in Bangladesh.
Trial summary
The purpose of the study is to determine whether vitamin A can improve survival and facilitate recovery from sepsis and necrotizing enterocolitis in hospitalized neonates. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Sepsis, Necrotizing Enterocolitis, Meningitis
- What is being tested?
- Vitamin A
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 424 participants
- Where
- 1 siteBangladesh
- Study dates
- Dec 2006to Jun 2012
- Phase
- Phase 3
- 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 1 day to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- newborns less than 29 days with clinical sepsis
Who cannot join
- healthy infants
- major congenital abnormalities
- known inborn error(s) of metabolism
- chronic disorders of other organs (e.g. cholestasis)
- definite or severe NEC (> stage 2)
- congenital heart disease
Show all 9Show fewer
- Infants receiving VA supplements
- Infants requiring mechanical ventilation
- Infant is unconscious
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Vitamin A in the Treatment of Sepsis and Necrotizing Enterocolitis in Hospitalized Neonates
The purpose of the study is to determine whether vitamin A can improve survival and facilitate recovery from sepsis and necrotizing enterocolitis in hospitalized neonates.
Read the detailed description
Sepsis and necrotizing enterocolitis (NEC) are leading causes of morbidity and mortality in neonates. Studies have shown that early reversal of the signs associated with severe disease is an important prognostic factor during acute illness. Vitamin A deficiency is widespread among children, including neonates, in developing countries. Vitamin A plays an important role in mediating immune responses and in maintaining epithelial integrity. For this reason vitamin A supplementation during the acute phase of neonatal infection could work synergistically with present antibiotic regimens in promoting early reversal of signs associated with adverse outcome and shorten the total duration of clinical illness. The purpose of the proposed hospital-based clinical trial is to evaluate the efficacy of vitamin A supplementation on reducing the morbidity and mortality among neonates hospitalized with sepsis (n=366) and NEC(n=150). Enrolled subjects will be randomized at the time of hospitalization to receive one dose of either 50,000 IU of vitamin A or placebo at enrollment, in addition to standard antibiotic therapy. We will compare the proportion of treatment failures in sepsis patients, the frequency of disease progression and mortality in NEC patients, and the time to clinical recovery and discharge between treatment groups. In addition, the study will determine whether vitamin A reduces pro-inflammatory cytokine levels; elevated host inflammatory cytokines are thought to contribute to the severity of both conditions. If vitamin A is found to be efficacious in the treatment of sepsis and NEC it could present a needed cost-effective approach to decreasing the global morbidity, mortality and the economic cost associated with neonatal sepsis and NEC in the developing world.
- Conditions
- Sepsis, Necrotizing Enterocolitis, Meningitis, Pneumonia
- Being tested
- Vitamin A
- Keywords
- vitamin A, Treatment, neonates, newborn, sepsis, necrotizing enterocolitis, meningitis, pneumonia
- Medical subject headings
- Sepsis, Enterocolitis, Necrotizing, Meningitis, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin ADietary supplement
Also called Retinol
50,000 IU of Vitamin A 50,000 IU of vegetable oil
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Sepsis - vitamin A Receives: Dietary Supplement: Vitamin A |
| 2 | Placebo comparator | Sepsis - placebo Receives: Dietary Supplement: Vitamin A |
| 3 | Experimental | NEC - vitamin A Receives: Dietary Supplement: Vitamin A |
| 4 | Placebo comparator | NEC - Placebo Receives: Dietary Supplement: Vitamin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Mortality
Measured: prospective
Secondary outcomes (3)
Inflammatory cytokine concentration
Measured: prospective
Duration of inflammation
Measured: prospective
Disease progression in NEC patients
Measured: prospective
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2008 (estimated)
- Study startDec 2006
- Primary completionApr 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 424 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, United States Agency for International Development (USAID), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Christian Coles, Johns Hopkins University
- Investigators
- Christian L Coles, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00707785
- Sponsor's protocol ID
- H.22.05.12.20.A2
- Other IDs
- 1K01DK075478-01
- Status last verified
- Sep 2013
- First submitted
- 27 Jun 2008
- Last updated
- 25 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin A in the Treatment of Sepsis and Necrotizing Enterocolitis in Hospitalized Neonates
- ClinicalTrials.gov ID
- NCT00707785
- Acronym / sponsor ID
- H.22.05.12.20.A2
- Conditions
- Sepsis, Necrotizing Enterocolitis, Meningitis, Pneumonia
- Keywords
- vitamin A, Treatment, neonates, newborn, sepsis, necrotizing enterocolitis, meningitis, pneumonia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 424 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, United States Agency for International Development (USAID), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Dec 2006
- Primary completion
- Apr 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 1 Jul 2008 (estimated)
- 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 purpose of the study is to determine whether vitamin A can improve survival and facilitate recovery from sepsis and necrotizing enterocolitis in hospitalized neonates.
Detailed description
Sepsis and necrotizing enterocolitis (NEC) are leading causes of morbidity and mortality in neonates. Studies have shown that early reversal of the signs associated with severe disease is an important prognostic factor during acute illness. Vitamin A deficiency is widespread among children, including neonates, in developing countries. Vitamin A plays an important role in mediating immune responses and in maintaining epithelial integrity. For this reason vitamin A supplementation during the acute phase of neonatal infection could work synergistically with present antibiotic regimens in promoting early reversal of signs associated with adverse outcome and shorten the total duration of clinical illness. The purpose of the proposed hospital-based clinical trial is to evaluate the efficacy of vitamin A supplementation on reducing the morbidity and mortality among neonates hospitalized with sepsis (n=366) and NEC(n=150). Enrolled subjects will be randomized at the time of hospitalization to receive one dose of either 50,000 IU of vitamin A or placebo at enrollment, in addition to standard antibiotic therapy. We will compare the proportion of treatment failures in sepsis patients, the frequency of disease progression and mortality in NEC patients, and the time to clinical recovery and discharge between treatment groups. In addition, the study will determine whether vitamin A reduces pro-inflammatory cytokine levels; elevated host inflammatory cytokines are thought to contribute to the severity of both conditions. If vitamin A is found to be efficacious in the treatment of sepsis and NEC it could present a needed cost-effective approach to decreasing the global morbidity, mortality and the economic cost associated with neonatal sepsis and NEC in the developing world.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Vitamin ASepsis - vitamin A |
| 2 | Placebo comparator | Dietary Supplement: Vitamin ASepsis - placebo |
| 3 | Experimental | Dietary Supplement: Vitamin ANEC - vitamin A |
| 4 | Placebo comparator | Dietary Supplement: Vitamin ANEC - Placebo |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- newborns less than 29 days with clinical sepsis
Key exclusion criteria (9 listed)
- healthy infants
- major congenital abnormalities
- known inborn error(s) of metabolism
- chronic disorders of other organs (e.g. cholestasis)
- definite or severe NEC (> stage 2)
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 AAlso: Retinol50,000 IU of Vitamin A 50,000 IU of vegetable oil | Dietary supplement | 1, 2, 3, 4 |
Primary outcome
Disease Mortality
Time frame: prospective
3 secondary outcomes
Inflammatory cytokine concentration
Time frame: prospective
Duration of inflammation
Time frame: prospective
Disease progression in NEC patients
Time frame: prospective
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2013.
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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.
Christian L Coles, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin A in people with Sepsis and Necrotizing Enterocolitis, run by Johns Hopkins University at 1 site in Bangladesh.
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 1 inclusion and 9 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: finished, as of the sponsor's last update on 25 Sep 2013. 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 Bangladesh. 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. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Disease Mortality (time frame: prospective). 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 25 Sep 2013.