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.
Name: Vitamin A (<3-day postpartum)
Description: Single dose 200,000 IU vitamin A supplementation at <3-day and placebo supplementation at 6-wk postpartum.Type: Dietary SupplementEarly postpartum vitamin A suppl.
Name: Vitamin A (6 wk postpartum)
Description: Placebo supplementation at <3-day and single dose 200,000 IU vitamin A supplementation at 6-wk postpartum.Type: Dietary SupplementLate postpartum vitamin A suppl.
Name: Vitamin A (<3-day and 6 wk postpartum)
Description: 200,000 IU vitamin A supplementation, both at <3-day and 6-wk postpartumType: Dietary SupplementEarly Early & Early & late postpartum vitamin A suppl
Name: Placebo
Description: Placebo supplementation, both at <3-day and 6-wk postpartum.Type: Dietary SupplementNo postpartum vitamin A suppl.
Description: 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- < 3-day postpartum (before 1st dose of supplementation) 7 wk postpartum (1wk after 2nd dose of supplementation) 15 wk postpartum
Measure: Breast milk immune regulators Time: Four monthsDescription: Mitogen stimulated whole blood IL-10, IL-13, IFN-gamma, IL-21 and IL-17 responses at two time points- 7 wk of age (1wk after 2nd dose of maternal supplementation , as well as, 1wk after first doses of pentavalent vaccination) 15 wk of age (1wk after three doses of pentavalent vaccination)
Measure: Infant T helper cell immune responses Time: Four monthsDescription: Tall like receptor (TLR)-4 and TLR9 agonist stimulated whole blood TNF-alpha and IL-10 and IFN-alpha responses at two time points- 7 wk of age (1wk after 2nd dose of maternal supplementation , as well as, 1wk after first doses of pentavalent vaccination) 15 wk of age (1wk after three doses of pentavalent vaccination)
Measure: Infant innate immune responses Time: Four monthsDescription: 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- 7 wk of age (1wk after 2nd dose of maternal supplementation , as well as, 1wk after first doses of pentavalent vaccination) 15 wk of age (1wk after three doses of pentavalent vaccination)
Measure: Infant vaccines (Hepatitis B, Tetanus and Oral polio) specific antibody responses Time: Four monthsDescription: 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- 7 wk of age (1wk after 2nd dose of maternal supplementation , as well as, 1wk after first doses of pentavalent vaccination) 15 wk of age (1wk after three doses of pentavalent vaccination)
Measure: Relative abundance of infant gut microbial community and gut inflammatory markers Time: Four monthsDescription: Infant plasma vitamin A status at 7 wk and 15 wk of age
Measure: Infant vitamin A status Time: Four monthsDescription: Infant Weight-for-Age z-score (WAZ) at 7 wk and 15 wk of age
Measure: Infant growth Time: Four monthsDescription: Infant morbidity status up to four months of age
Measure: Infant morbidity Time: Four monthsDescription: Plasma Retinol Binding Protein (RBP) and breast milk vitamin A level at two time points- < 3-day postpartum (before 1st dose of supplementation) 15 wk postpartum
Measure: Mother vitamin A status Time: Four monthsAllocation: Randomized
Parallel Assignment
There is one SNP
human β-defensin-2 (HBD2); Neopterin; α-1-antitrypsin (AAT); neutrophil gelatinase-associated lipocalin (NGAL)-2 and S100A at two time points- 7 wk of age (1wk after 2nd dose of maternal supplementation , as well as, 1wk after first doses of pentavalent vaccination) 15 wk of age (1wk after three doses of pentavalent vaccination). --- S100A ---