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Vitamin A and Maternal-infant Flu Vaccine Response

NCT00817661 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2013-01-03

No results posted yet for this study

Summary

Influenza viral infection can cause serious illness among young infants 0-6 months of age. However, inactivated influenza vaccine is not recommended for this age group but pregnant women can be vaccinated during 2nd - 3rd trimester to induce passive immunization of their infants. Nevertheless vitamin A deficiency is highly prevalent among pregnant women in Bangladesh, \>50% pregnant women consume less vitamin A than the recommended level. Given the fact that both clinical and sub-clinical vitamin A deficiency impair vaccine specific immunity, in this proposed study, we aim to investigate whether maternal vitamin A supplementation improve influenza vaccine specific immune responses among pregnant women and the passive protection of their infants.

In a placebo controlled clinical trial, sixty six mothers will be randomly assigned to receive either 10,000 IU vitamin A or placebo capsules weekly from second trimester to 6 month postnatal period. At 26-28 weeks of gestation, all mothers will be vaccinated with inactivated, trivalent influenza virus vaccine. Maternal and cord blood will be collected for vitamin A and influenza virus specific IgG assessment. Colostrum and breast milk at 6-month will be collected for vitamin A and influenza virus specific secretory IgA assessment. Venous blood (2-3 ml) will be obtained from all infants at the age of 6 months for vitamin A and influenza virus specific IgG assessment as well as infants' nasal swab for influenza virus specific secretory IgA.

Conditions

Interventions

DIETARY_SUPPLEMENT

Vitamin A

10000 IU Vitamin A or placebo per week

DIETARY_SUPPLEMENT

Placebo

10000 IU Vitamin A or placebo per week

Sponsors & Collaborators

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    lead OTHER

Principal Investigators

  • Shaikh M Ahmad, Ph.D. · International Centre for Diarrhoeal Disease Research, Bangladesh

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • Bangladesh

Study Locations

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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 NCT00817661 on ClinicalTrials.gov