Vitamin A and Maternal-infant Flu Vaccine Response

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier:
NCT00817661
First received: January 4, 2009
Last updated: January 1, 2013
Last verified: January 2009
  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

Resource links provided by NLM:


Further study details as provided by International Centre for Diarrhoeal Disease Research, Bangladesh:

Primary Outcome Measures:
  • Peripheral blood serum Vitamin A Peripheral blood serum Influenza IgG Cord blood plasma Vitamin A Cord blood plasma Influenza IgG Colostrum Vitamin A Colostrum Influenza sIgA [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mothers (6 mo postpartum) serum Vitamin A serum Influ IgG Breast milk Vitamin A, Influ sIgA Infants (6 mo) Anthropometry serum Vitamin A serum Influ IgG Nasal Influ sIgA [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Mothers (6 mo postpartum) serum Vitamin A serum Influenza IgG Breast milk Vitamin A Breast milk Influenza sIgA Infants (6 mo) Anthropometry serum Vitamin A serum Influenza IgG [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 66
Study Start Date: February 2009
Study Completion Date: July 2010
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
Criteria

Inclusion Criteria:

  • mothers at the beginning of second trimester (i.e. approximately 12 weeks of gestation)
  • willing to stay in Dhaka during pregnancy and willing to admit in the clinic at delivery
  • the gestational age will be determined by self-reported LMP, which is likely be underestimated in most cases. A two-week variation will be acceptable in this proposed study

Exclusion Criteria:

  • history of systemic disease
  • previous complicated pregnancies or of pre-term delivery
  • abortion
  • congenital anomaly
  • hypersensitivity to influenza vaccine or receipt of the vaccine
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00817661

Locations
Bangladesh
Shaikh M Ahmad
Dhaka, Bangladesh, 1212
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Investigators
Principal Investigator: Shaikh M Ahmad, Ph.D. International Centre for Diarrhoeal Disease Research, Bangladesh
  More Information

No publications provided

Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT00817661     History of Changes
Other Study ID Numbers: 2008-069
Study First Received: January 4, 2009
Last Updated: January 1, 2013
Health Authority: Bangladesh: Ethical Review Committee

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
vitamin A
influenza vaccine
passive immunity
pregnant mothers
vitamin A suplementation
Influenza vaccination
Infant immune responses

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
Respiratory Tract Diseases
Respiratory Tract Infections
RNA Virus Infections
Virus Diseases
Retinol palmitate
Vitamin A
Vitamins
Anticarcinogenic Agents
Antineoplastic Agents
Antioxidants
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014