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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

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.

Condition or disease Intervention/treatment Phase
Vitamin A Deficiency 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 Phase 2 Phase 3

Detailed Description:
The effect will be assessed by the milk and blood.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Stopping Postpartum Vitamin A Supplementation: Are we Missing Concealed Benefit?
Study Start Date : October 2013
Actual Primary Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Early postpartum vitamin A suppl.
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)
Single dose 200,000 IU vitamin A supplementation at <3-day and placebo supplementation at 6-wk 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.
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.

Experimental: Early & late postpartum vitamin A suppl
200,000 IU vitamin A supplementation, both at <3-day and 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

Experimental: No postpartum vitamin A suppl.
Placebo supplementation, both at <3-day and 6-wk postpartum.
Dietary Supplement: Placebo
Placebo supplementation, both at <3-day and 6-wk postpartum.




Primary Outcome Measures :
  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-

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


Secondary Outcome Measures :
  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-

    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)

  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-

    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)

  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-

    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)

  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-

    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 Outcome Measures:
  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-

    1. < 3-day postpartum (before 1st dose of supplementation)
    2. 15 wk postpartum



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Ages Eligible for Study:   18 Years to 32 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02043223


Locations
Bangladesh
International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka, Bangladesh, 1212
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Peter Bergman, MD, PhD
Karolinska University Hospital
Investigators
Principal Investigator: Shaikh M Ahmad, Ph.D International Centre for Diarrhoeal Disease Research, Bangladesh

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT02043223     History of Changes
Other Study ID Numbers: PR-13060
First Posted: January 23, 2014    Key Record Dates
Last Update Posted: September 21, 2016
Last Verified: September 2016

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Vitamin A
Breast milk
Postpartum vitamin A supplementation
Infant vaccine response

Additional relevant MeSH terms:
Vitamin A Deficiency
Night Blindness
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vision Disorders
Eye Diseases
Vitamins
Vitamin A
Retinol palmitate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents