Vitamin A Deficiency
Conditions
Keywords
Vitamin A, Breast milk, Postpartum vitamin A supplementation, Infant vaccine response
Brief summary
The purpose of this study is to evaluate the effect of post-partum maternal vitamin A supplementation on breast milk bioactive compounds and immune status, growth and morbidity of children in the first four months of life.
Detailed description
The effect will be assessed by the milk and blood.
Interventions
DIETARY_SUPPLEMENTVitamin A (<3-day postpartum)
Single dose 200,000 IU vitamin A supplementation at \<3-day and placebo supplementation at 6-wk postpartum.
DIETARY_SUPPLEMENTVitamin A (6 wk postpartum)
Placebo supplementation at \<3-day and single dose 200,000 IU vitamin A supplementation at 6-wk postpartum.
DIETARY_SUPPLEMENTVitamin A (<3-day and 6 wk postpartum)
200,000 IU vitamin A supplementation, both at \<3-day and 6-wk postpartum
DIETARY_SUPPLEMENTPlacebo
Placebo supplementation, both at \<3-day and 6-wk postpartum.
Sponsors
Peter Bergman, MD, PhD
Karolinska University Hospital
International Centre for Diarrhoeal Disease Research, Bangladesh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 32 Years
Healthy volunteers
Yes
Inclusion criteria
* Pregnant women \>-18 years of age with low-risk obstetric
Exclusion criteria
* Pregnant women expecting a multiple birth * Take vitamin A supplements during postpartum apart from study intervention * Premature birth * Newborn babies with birth defects and / or other serious diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breast milk immune regulators | Four months | immune regulators in breast milk e.g. B-cell activating factor (BAFF); IL-7; Lactoferrin; sCD14, sIgA and TGF-beta levels at three time points- 1. \< 3-day postpartum (before 1st dose of supplementation) 2. 7 wk postpartum (1wk after 2nd dose of supplementation) 3. 15 wk postpartum |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infant T helper cell immune responses | Four months | Mitogen stimulated whole blood IL-10, IL-13, IFN-gamma, IL-21 and IL-17 responses at two time points- 1. 7 wk of age (1wk after 2nd dose of maternal supplementation , as well as, 1wk after first doses of pentavalent vaccination) 2. 15 wk of age (1wk after three doses of pentavalent vaccination) |
| Infant innate immune responses | Four months | Tall like receptor (TLR)-4 and TLR9 agonist stimulated whole blood TNF-alpha and IL-10 and IFN-alpha responses at two time points- 1. 7 wk of age (1wk after 2nd dose of maternal supplementation , as well as, 1wk after first doses of pentavalent vaccination) 2. 15 wk of age (1wk after three doses of pentavalent vaccination) |
| Infant vaccines (Hepatitis B, Tetanus and Oral polio) specific antibody responses | Four months | Hepatitis B and Tetanus Toxoid specific plasma cell IgG responses at 15 wk of age (1wk after three doses of pentavalent vaccination) And Hepatitis B and Tetanus Toxoid specific IgG in plasma and Polio (3 serotypes) specific secretory IgA (sIgA) in stool at two time points- 1. 7 wk of age (1wk after 2nd dose of maternal supplementation , as well as, 1wk after first doses of pentavalent vaccination) 2. 15 wk of age (1wk after three doses of pentavalent vaccination) |
| Relative abundance of infant gut microbial community and gut inflammatory markers | Four months | Next generation sequencing (NGS) of bacterial 16s rDNA (+qPCR) in extracted stool samples and assessment of infant gut inflammatory markers e.g. human β-defensin-2 (HBD2); Neopterin; α-1-antitrypsin (AAT); neutrophil gelatinase-associated lipocalin (NGAL)-2 and S100A at two time points- 1. 7 wk of age (1wk after 2nd dose of maternal supplementation , as well as, 1wk after first doses of pentavalent vaccination) 2. 15 wk of age (1wk after three doses of pentavalent vaccination) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Infant growth | Four months | Infant Weight-for-Age z-score (WAZ) at 7 wk and 15 wk of age |
| Infant morbidity | Four months | Infant morbidity status up to four months of age |
| Mother vitamin A status | Four months | Plasma Retinol Binding Protein (RBP) and breast milk vitamin A level at two time points- 1. \< 3-day postpartum (before 1st dose of supplementation) 2. 15 wk postpartum |
| Infant vitamin A status | Four months | Infant plasma vitamin A status at 7 wk and 15 wk of age |
Countries
Bangladesh
Outcome results
None listed