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Sponsored by: |
International Centre for Diarrhoeal Disease Research, Bangladesh |
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Information provided by: | International Centre for Diarrhoeal Disease Research, Bangladesh |
ClinicalTrials.gov Identifier: | NCT00817661 |
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.
Condition | Intervention |
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Influenza |
Dietary Supplement: Vitamin A Dietary Supplement: Placebo |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Effect of Maternal Vitamin A Supplementation on Maternal Immune Response to Inactivated Influenza Vaccination, and on Passive Protection of Infants |
Estimated Enrollment: | 66 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Vitamin A group
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Dietary Supplement: Vitamin A
10000 IU Vitamin A or placebo per week
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2: Placebo Comparator
Placebo group
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Dietary Supplement: Placebo
10000 IU Vitamin A or placebo per week
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Ages Eligible for Study: | 22 Years to 35 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Shaikh M Ahmad, Ph.D. | 8860523-32 ext 2413 | smeahmad@icddrb.org |
Bangladesh | |
Shaikh M Ahmad | |
Dhaka, Bangladesh, 1212 |
Principal Investigator: | Shaikh M Ahmad, Ph.D. | International Centre for Diarrhoeal Disease Research, Bangladesh |
Responsible Party: | International Centre for Diarrhoeal Diseases Research, Bangladesh ( Dr. Shaikh Meshbahuddin Ahmad ) |
Study ID Numbers: | 2008-069 |
Study First Received: | January 4, 2009 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00817661 History of Changes |
Health Authority: | Bangladesh: Ethical Review Committee |
vitamin A influenza vaccine passive immunity pregnant mothers |
vitamin A suplementation Influenza vaccination Infant immune responses |
Anticarcinogenic Agents Retinol Antioxidants Trace Elements Orthomyxoviridae Infections Virus Diseases Respiratory Tract Infections |
Respiratory Tract Diseases Retinol palmitate Vitamins Vitamin A Influenza, Human Micronutrients |
Anticarcinogenic Agents RNA Virus Infections Antioxidants Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Orthomyxoviridae Infections Protective Agents Pharmacologic Actions |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases Retinol palmitate Therapeutic Uses Vitamin A Vitamins Influenza, Human Micronutrients |