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Vitamin A and Very Low Birthweight Babies (VitAL)

NCT00417404 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2010-06-25

No results posted yet for this study

Summary

Vitamin A is important for the development of healthy eyes and lungs. Very low birth weight premature babies have low body stores of vitamin A and are prone to diseases of the eye and lungs. Previous work has shown that intramuscular (IM) vitamin A reduces the number of babies who require prolonged oxygen therapy, and may also reduce the number of babies affected by retinopathy of prematurity (ROP)). There is also some evidence that the conjunctiva shows signs of deficiency of vitamin A in premature infants, particularly those who develop ROP. Our own work here in Glasgow suggests that, compared to babies born at full term, premature babies' eyes are less sensitive to light and we believe that this may reflect shortage of vitamin A in the eye. This study will examine the effects upon the eye of giving extra intramuscular vitamin A to very low birth weight, premature infants. We will also measure blood levels of vitamin A and calculate liver stores of this nutrient.

Conditions

Interventions

DRUG

Aquasol A

IM Aquasol A 10,000IU three times weekly

DRUG

aquasol A

10,000 IU three times weeks, by intramuscular injection

OTHER

sham injection

sham injection

Sponsors & Collaborators

  • Chief Scientist Office of the Scottish Government

    collaborator OTHER_GOV

  • Glasgow Royal Infirmary

    lead OTHER

Principal Investigators

  • Helen Mactier, MD · Glasgow Royal Infirmary

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
24 Hours
Max Age
72 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00417404 on ClinicalTrials.gov