Stopping Postpartum Vitamin A Supplementation: Missing Concealed Benefit

Vitamin A Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02043223
• Other study ID #: PR-13060
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 5, 2013
• Last updated: September 20, 2016
• Start date: October 2013

Study information

• Verified date: September 2016
• Source: International Centre for Diarrhoeal Disease Research, Bangladesh
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bangladesh: Ethical Review Committee
• Study type: Interventional

Clinical Trial 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.

Description:

The effect will be assessed by the milk and blood.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 32 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Night Blindness
• Vitamin A Deficiency

Intervention

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.
• Vitamin A (6 wk postpartum)
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)
200,000 IU vitamin A supplementation, both at <3-day and 6-wk postpartum
• Placebo
Placebo supplementation, both at <3-day and 6-wk postpartum.

Locations

Country	Name	City	State
Bangladesh	International Centre for Diarrhoeal Disease Research, Bangladesh	Dhaka

Sponsors (3)

Lead Sponsor	Collaborator
International Centre for Diarrhoeal Disease Research, Bangladesh	Karolinska University Hospital, Peter Bergman, MD, PhD

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Infant vitamin A status	Infant plasma vitamin A status at 7 wk and 15 wk of age	Four months	No
Other	Infant growth	Infant Weight-for-Age z-score (WAZ) at 7 wk and 15 wk of age	Four months	No
Other	Infant morbidity	Infant morbidity status up to four months of age	Four months	No
Other	Mother vitamin A status	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	Four months	No
Primary	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	Four months	No
Secondary	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)	Four months	No
Secondary	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)	Four months	No
Secondary	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)	Four months	No
Secondary	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 ß-defensin-2 (HBD2); Neopterin; a-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)	Four months	No