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Stopping Postpartum Vitamin A Supplementation: Missing Concealed Benefit

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ClinicalTrials.gov Identifier: NCT02043223
Recruitment Status : Completed
First Posted : January 23, 2014
Last Update Posted : September 21, 2016
Sponsor:
Collaborators:
Peter Bergman, MD, PhD
Karolinska University Hospital
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh

December 5, 2013
January 23, 2014
September 21, 2016
October 2013
July 2016   (Final data collection date for primary outcome measure)
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-

  1. < 3-day postpartum (before 1st dose of supplementation)
  2. 7 wk postpartum (1wk after 2nd dose of supplementation)
  3. 15 wk postpartum
  • Breast milk TGF-beta [ Time Frame: Four months ]

    At three time points-

    1. < 3-day postpartum (before supplementation)
    2. 7 wk postpartum (1wk after 2nd dose of supplementation)
    3. 15 wk postpartum
  • Breast milk secretory IgA (sIgA) [ Time Frame: Four months ]

    At three time points-

    1. < 3-day postpartum (before supplementation)
    2. 7 wk postpartum (1wk after 2nd dose of supplementation)
    3. 15 wk postpartum
Complete list of historical versions of study NCT02043223 on ClinicalTrials.gov Archive Site
  • 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-

    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 [ 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-

    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 [ 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-

    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 [ 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-

    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 T helper cell immune responses [ Time Frame: Four months ]

    PHA stimulated whole blood IL-10, IL-13, IFN-gamma 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 [ 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-

    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 vitamin A status [ Time Frame: Four months ]
    Infant plasma vitamin A status at 7 wk and 15 wk of age
  • Infant growth [ Time Frame: Four months ]
    Infant Weight-for-Age z-score (WAZ) at 7 wk and 15 wk of age
  • Infant morbidity [ Time Frame: Four months ]
    Infant morbidity status up to four months of age
  • Mother vitamin A status [ Time Frame: 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 [ Time Frame: Four months ]
    Infant plasma vitamin A status at 7 wk and 15 wk of age
  • Infant growth [ Time Frame: Four months ]
    Infant Weight-for-Age z-score (WAZ) at 7 wk and 15 wk of age
  • Infant morbidity [ Time Frame: Four months ]
    Infant morbidity status up to four months of age
 
Stopping Postpartum Vitamin A Supplementation: Missing Concealed Benefit
Stopping Postpartum Vitamin A Supplementation: Are we 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.
The effect will be assessed by the milk and blood.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Vitamin A Deficiency
  • Dietary Supplement: Vitamin A (<3-day postpartum)
    Single dose 200,000 IU vitamin A supplementation at <3-day and placebo supplementation at 6-wk postpartum.
  • Dietary Supplement: Vitamin A (6 wk postpartum)
    Placebo supplementation at <3-day and single dose 200,000 IU vitamin A supplementation at 6-wk postpartum.
  • Dietary Supplement: Vitamin A (<3-day and 6 wk postpartum)
    200,000 IU vitamin A supplementation, both at <3-day and 6-wk postpartum
  • Dietary Supplement: Placebo
    Placebo supplementation, both at <3-day and 6-wk postpartum.
  • Experimental: Early postpartum vitamin A suppl.
    Single dose 200,000 IU vitamin A supplementation at <3-day and placebo supplementation at 6-wk postpartum.
    Intervention: Dietary Supplement: Vitamin A (<3-day postpartum)
  • Experimental: Late postpartum vitamin A suppl.
    Placebo supplementation at <3-day and single dose 200,000 IU vitamin A supplementation at 6-wk postpartum.
    Intervention: Dietary Supplement: Vitamin A (6 wk postpartum)
  • Experimental: Early & late postpartum vitamin A suppl
    200,000 IU vitamin A supplementation, both at <3-day and 6-wk postpartum
    Intervention: Dietary Supplement: Vitamin A (<3-day and 6 wk postpartum)
  • Experimental: No postpartum vitamin A suppl.
    Placebo supplementation, both at <3-day and 6-wk postpartum.
    Intervention: Dietary Supplement: Placebo
Ahmad SM, Hossain MI, Bergman P, Kabir Y, Raqib R. The effect of postpartum vitamin A supplementation on breast milk immune regulators and infant immune functions: study protocol of a randomized, controlled trial. Trials. 2015 Mar 31;16:129. doi: 10.1186/s13063-015-0654-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
128
Not Provided
July 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 32 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Bangladesh
 
 
NCT02043223
PR-13060
Yes
Not Provided
Not Provided
International Centre for Diarrhoeal Disease Research, Bangladesh
International Centre for Diarrhoeal Disease Research, Bangladesh
  • Peter Bergman, MD, PhD
  • Karolinska University Hospital
Principal Investigator: Shaikh M Ahmad, Ph.D International Centre for Diarrhoeal Disease Research, Bangladesh
International Centre for Diarrhoeal Disease Research, Bangladesh
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP