Stopping Postpartum Vitamin A Supplementation: Missing Concealed Benefit

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Bangladesh

Study Type

Interventional

Intervention

Vitamin A (<3-day postpartum)

Vitamin A (6 wk postpartum)

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

Placebo

About this trial

This is an interventional prevention trial for Vitamin A Deficiency focused on measuring Vitamin A, Breast milk, Postpartum vitamin A supplementation, Infant vaccine response

Eligibility Criteria

18 Years - 32 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

International Centre for Diarrhoeal Disease Research, Bangladesh

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Early postpartum vitamin A suppl.

Late postpartum vitamin A suppl.

Early & late postpartum vitamin A suppl

No postpartum vitamin A suppl.

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

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)

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)

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)

Full Information

NCT ID

NCT02043223

First Posted

December 5, 2013

Last Updated

September 20, 2016

Sponsor

International Centre for Diarrhoeal Disease Research, Bangladesh

Collaborators

Peter Bergman, MD, PhD, Karolinska University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02043223

Brief Title

Stopping Postpartum Vitamin A Supplementation: Missing Concealed Benefit

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

October 2013 (undefined)

Primary Completion Date

July 2016 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

International Centre for Diarrhoeal Disease Research, Bangladesh

Collaborators

Peter Bergman, MD, PhD, Karolinska University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

The effect will be assessed by the milk and blood.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitamin A Deficiency

Keywords

Vitamin A, Breast milk, Postpartum vitamin A supplementation, Infant vaccine response

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

160 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Early postpartum vitamin A suppl.

Arm Type

Experimental

Arm Description

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

Arm Title

Late postpartum vitamin A suppl.

Arm Type

Experimental

Arm Description

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

Arm Title

Early & late postpartum vitamin A suppl

Arm Type

Experimental

Arm Description

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

Arm Title

No postpartum vitamin A suppl.

Arm Type

Experimental

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin A (<3-day postpartum)

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin A (6 wk postpartum)

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

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

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Breast milk immune regulators

Description

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

Time Frame

Four months

Secondary Outcome Measure Information:

Title

Infant T helper cell immune responses

Description

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)

Time Frame

Four months

Title

Infant innate immune responses

Description

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)

Time Frame

Four months

Title

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

Description

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)

Time Frame

Four months

Title

Relative abundance of infant gut microbial community and gut inflammatory markers

Description

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)

Time Frame

Four months

Other Pre-specified Outcome Measures:

Title

Infant vitamin A status

Description

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

Time Frame

Four months

Title

Infant growth

Description

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

Time Frame

Four months

Title

Infant morbidity

Description

Infant morbidity status up to four months of age

Time Frame

Four months

Title

Mother vitamin A status

Description

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

Time Frame

Four months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

32 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shaikh M Ahmad, Ph.D

Organizational Affiliation

International Centre for Diarrhoeal Disease Research, Bangladesh

Official's Role

Principal Investigator

Facility Information:

Facility Name

International Centre for Diarrhoeal Disease Research, Bangladesh

City

Dhaka

ZIP/Postal Code

1212

Country

Bangladesh

12. IPD Sharing Statement

Citations:

PubMed Identifier

25872802

Citation

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.

Results Reference

derived

Vitamin A Deficiency

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial