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| Sponsor: | International Centre for Diarrhoeal Disease Research, Bangladesh |
|---|---|
| Information provided by: | International Centre for Diarrhoeal Disease Research, Bangladesh |
| ClinicalTrials.gov Identifier: | NCT00817661 |
Purpose
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 |
|---|---|
|
Influenza |
Dietary Supplement: Vitamin A Dietary Supplement: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| 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 |
|---|---|
|
Experimental: 1
Vitamin A group
|
Dietary Supplement: Vitamin A
10000 IU Vitamin A or placebo per week
|
|
Placebo Comparator: 2
Placebo group
|
Dietary Supplement: Placebo
10000 IU Vitamin A or placebo per week
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 22 Years to 35 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Shaikh M Ahmad, Ph.D. | 8860523-32 ext 2413 | smeahmad@icddrb.org |
| Bangladesh | |
| Shaikh M Ahmad | Not yet recruiting |
| Dhaka, Bangladesh, 1212 | |
| Contact: Shaikh M Ahmad, Ph. D. 8860523-32 ext 2413 smeahmad@icddrb.org | |
| Principal Investigator: Shaikh M Ahmad, Ph. D. | |
| Principal Investigator: | Shaikh M Ahmad, Ph.D. | International Centre for Diarrhoeal Disease Research, Bangladesh |
More Information
| Responsible Party: | Dr. Shaikh Meshbahuddin Ahmad, International Centre for Diarrhoeal Diseases Research, Bangladesh |
| ClinicalTrials.gov Identifier: | NCT00817661 History of Changes |
| Other Study ID Numbers: | 2008-069 |
| Study First Received: | January 4, 2009 |
| Last Updated: | January 5, 2009 |
| Health Authority: | Bangladesh: Ethical Review Committee |
|
vitamin A influenza vaccine passive immunity pregnant mothers |
vitamin A suplementation Influenza vaccination Infant immune responses |
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases Vitamin A Vitamins Retinol palmitate Micronutrients |
Growth Substances Physiological Effects of Drugs Pharmacologic Actions Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Anticarcinogenic Agents Antineoplastic Agents Therapeutic Uses |