NCT00063596

Brief Summary

Extremely low birth weight infants have decreased blood levels of Vitamin A. This Vitamin A deficiency may increase the risk of infections and chronic lung disease in these infants. This study will examine the effects of Vitamin A supplementation in premature babies born weighing less than 1500 grams (3.3 lbs).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2000

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2000

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 2, 2003

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
Last Updated

June 24, 2005

Status Verified

November 1, 2004

First QC Date

July 1, 2003

Last Update Submit

June 23, 2005

Conditions

Infant, Premature

Keywords

Vitamin AHepatitis B vaccineImmune responsesT-cell subsetsChronic lung diseaseCytokines, intracytoplasmicAntibodies, hepatitis B and tetanus toxoid

Outcome Measures

Primary Outcomes (1)

  • Response to Hepatitis B vaccine

Secondary Outcomes (5)

  • Chronic lung disease

  • Length of hospital stay

  • Respiratory and GI infections to 9 months of age

  • T-cell cytokine production and development

  • T-cell subset development

Interventions

Vitamin A supplementationDRUG

Eligibility Criteria

Age1 Day - 3 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Born at less than 32 weeks gestation
  • Weigh less than 1500 g (3.3 lbs) and more than 500 g (1.1 lbs)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's and Children's Hospital of Buffalo

Buffalo, New York, 14222, United States

Location

MeSH Terms

Conditions

Premature BirthHepatitis BTetanus

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesClostridium InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and Mycoses

Study Officials

  • Mark Ballow, MD

    State University of New York at Buffalo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

July 1, 2003

First Posted

July 2, 2003

Study Start

January 1, 2000

Study Completion

May 1, 2004

Last Updated

June 24, 2005

Record last verified: 2004-11

Locations

US(1)