NCT00707785

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
424

participants targeted

Target at P50-P75 for phase_3 sepsis

Timeline
Completed

Started Dec 2006

Longer than P75 for phase_3 sepsis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 1, 2008

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

September 25, 2013

Status Verified

September 1, 2013

Enrollment Period

4.3 years

First QC Date

June 27, 2008

Last Update Submit

September 24, 2013

Conditions

SepsisNecrotizing EnterocolitisMeningitisPneumonia

Keywords

vitamin ATreatmentneonatesnewbornsepsisnecrotizing enterocolitismeningitispneumonia

Outcome Measures

Primary Outcomes (1)

  • Disease Mortality

    prospective

Secondary Outcomes (3)

  • Inflammatory cytokine concentration

    prospective

  • Duration of inflammation

    prospective

  • Disease progression in NEC patients

    prospective

Other Outcomes (2)

  • Treatment failure

    prospective

  • Time to recovery from severe illness

    prospective

Study Arms (4)

1

EXPERIMENTAL

Sepsis - vitamin A

Dietary Supplement: Vitamin A

2

PLACEBO COMPARATOR

Sepsis - placebo

Dietary Supplement: Vitamin A

3

EXPERIMENTAL

NEC - vitamin A

Dietary Supplement: Vitamin A

4

PLACEBO COMPARATOR

NEC - Placebo

Dietary Supplement: Vitamin A

Interventions

Vitamin ADIETARY_SUPPLEMENT

50,000 IU of Vitamin A 50,000 IU of vegetable oil

Also known as: Retinol
1234

Eligibility Criteria

Age1 Day - 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • newborns less than 29 days with clinical sepsis

You may not qualify if:

  • 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
  • Infants receiving VA supplements
  • Infants requiring mechanical ventilation
  • Infant is unconscious

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dhaka Shishu Hospital

Dhaka, Bangladesh

Location

MeSH Terms

Conditions

SepsisEnterocolitis, NecrotizingMeningitisPneumonia

Interventions

Vitamin A

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsEnterocolitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesNeuroinflammatory DiseasesNervous System DiseasesRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalBiological Factors

Study Officials

  • Christian L Coles, PhD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of International Health

Study Record Dates

First Submitted

June 27, 2008

First Posted

July 1, 2008

Study Start

December 1, 2006

Primary Completion

April 1, 2011

Study Completion

June 1, 2012

Last Updated

September 25, 2013

Record last verified: 2013-09

Locations

BA(1)