Stopping Postpartum Vitamin A Supplementation: Missing Concealed Benefit

Study Overview
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Brief Summary
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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
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The effect will be assessed by the milk and blood.

Official Title
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Stopping Postpartum Vitamin A Supplementation: Are we Missing Concealed Benefit?

Conditions
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Vitamin A Deficiency

Intervention / Treatment
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* Dietary Supplement: Vitamin A (<3-day postpartum)
* Dietary Supplement: Vitamin A (6 wk postpartum)
* Dietary Supplement: Vitamin A (<3-day and 6 wk postpartum)
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 32 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early postpartum vitamin A suppl.<br>Single dose 200,000 IU vitamin A supplementation at <3-day and placebo supplementation at 6-wk postpartum. | Dietary Supplement: Vitamin A (<3-day postpartum)<br>* Single dose 200,000 IU vitamin A supplementation at <3-day and placebo supplementation at 6-wk postpartum.<br>|
| Experimental: Late postpartum vitamin A suppl.<br>Placebo supplementation at <3-day and single dose 200,000 IU vitamin A supplementation at 6-wk postpartum. | Dietary Supplement: Vitamin A (6 wk postpartum)<br>* Placebo supplementation at <3-day and single dose 200,000 IU vitamin A supplementation at 6-wk postpartum.<br>|
| Experimental: Early & late postpartum vitamin A suppl<br>200,000 IU vitamin A supplementation, both at <3-day and 6-wk postpartum | Dietary Supplement: Vitamin A (<3-day and 6 wk postpartum)<br>* 200,000 IU vitamin A supplementation, both at <3-day and 6-wk postpartum<br>|
| Experimental: No postpartum vitamin A suppl.<br>Placebo supplementation, both at <3-day and 6-wk postpartum. | Dietary Supplement: Placebo<br>* Placebo supplementation, both at <3-day and 6-wk postpartum.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breast milk immune regulators | 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 | Four months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant T helper cell immune responses | 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) | Four months | 
| Infant innate immune responses | 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) | Four months | 
| Infant vaccines (Hepatitis B, Tetanus and Oral polio) specific antibody responses | 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) | Four months | 
| Relative abundance of infant gut microbial community and gut inflammatory markers | 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) | Four months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin A, Breast milk, Postpartum vitamin A supplementation, Infant vaccine response