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Completed

NCT Number: NCT02043223

Stopping Postpartum Vitamin A Supplementation: Missing Concealed Benefit

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.

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Key information

Conditions

Vitamin A Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year–32 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, 1212, Bangladesh

About this study

The effect will be assessed by the milk and blood.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin A (<3-day postpartum)

Dietary Supplement

Single dose 200,000 IU vitamin A supplementation at <3-day and placebo supplementation at 6-wk postpartum.

Vitamin A (6 wk postpartum)

Dietary Supplement

Placebo supplementation at <3-day and single dose 200,000 IU vitamin A supplementation at 6-wk postpartum.

Vitamin A (<3-day and 6 wk postpartum)

Dietary Supplement

200,000 IU vitamin A supplementation, both at <3-day and 6-wk postpartum

Placebo

Dietary Supplement

Placebo supplementation, both at <3-day and 6-wk postpartum.

Primary outcomes

  1. Breast milk immune regulators

    Time frame: 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-

    • < 3-day postpartum (before 1st dose of supplementation)
    • 7 wk postpartum (1wk after 2nd dose of supplementation)
    • 15 wk postpartum

Secondary outcomes

  1. Infant T helper cell immune responses

    Time frame: Four months

    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)

  2. Infant innate immune responses

    Time frame: 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-

    • 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)

  3. Infant vaccines (Hepatitis B, Tetanus and Oral polio) specific antibody responses

    Time frame: 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-

    • 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)

  4. Relative abundance of infant gut microbial community and gut inflammatory markers

    Time frame: 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-

    • 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)

Other outcomes

  1. Infant vitamin A status

    Time frame: Four months

    Infant plasma vitamin A status at 7 wk and 15 wk of age

  2. Infant growth

    Time frame: Four months

    Infant Weight-for-Age z-score (WAZ) at 7 wk and 15 wk of age

  3. Infant morbidity

    Time frame: Four months

    Infant morbidity status up to four months of age

  4. Mother vitamin A status

    Time frame: Four months

    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

Sponsors and collaborators

Lead sponsor

International Centre for Diarrhoeal Disease Research, Bangladesh

Other

Collaborators

  • Karolinska University Hospital
  • Peter Bergman, MD, PhD

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
First posted
Jan 23, 2014
Registry last updated
Sep 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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