Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Stopping Postpartum Vitamin A Supplementation: Missing Concealed Benefit

This study has been completed.
Sponsor:
Collaborators:
Peter Bergman, MD, PhD
Karolinska University Hospital
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier:
NCT02043223
First received: December 5, 2013
Last updated: September 20, 2016
Last verified: September 2016
  Purpose
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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Stopping Postpartum Vitamin A Supplementation: Are we Missing Concealed Benefit?

Resource links provided by NLM:


Further study details as provided by International Centre for Diarrhoeal Disease Research, Bangladesh:

Primary Outcome Measures:
  • Breast milk immune regulators [ Time Frame: Four months ] [ Designated as safety issue: No ]

    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:
  • Infant T helper cell immune responses [ Time Frame: Four months ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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:
  • Infant vitamin A status [ Time Frame: Four months ] [ Designated as safety issue: No ]
    Infant plasma vitamin A status at 7 wk and 15 wk of age

  • Infant growth [ Time Frame: Four months ] [ Designated as safety issue: No ]
    Infant Weight-for-Age z-score (WAZ) at 7 wk and 15 wk of age

  • Infant morbidity [ Time Frame: Four months ] [ Designated as safety issue: No ]
    Infant morbidity status up to four months of age

  • Mother vitamin A status [ Time Frame: Four months ] [ Designated as safety issue: No ]

    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


Enrollment: 160
Study Start Date: October 2013
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years to 32 Years   (Adult)
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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 
Study First Received: December 5, 2013
Last Updated: September 20, 2016
Health Authority: Bangladesh: Ethical Review Committee

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

ClinicalTrials.gov processed this record on September 27, 2016