The effect of newborn vitamin A supplementation on infant immune functions

Trial design, interventions, and baseline data

Shaikh Meshbahuddin Ahmad, Rubhana Raqib, Firdausi Qadri, Charles B. Stephensen

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

In recent years, neonatal vitamin A supplementation is considered as an essential infant-survival intervention but the evidence is not conclusive. This randomized controlled clinical trial was conducted to evaluate the effect of vitamin A on immune competence in early infancy. Results would provide a mechanistic basis for understanding the effect of this intervention on infant survival. Within 2. days of birth, infants born at one maternity clinic located in a poor slum area of Dhaka city were supplemented with either 50,000. IU vitamin A or placebo. Live attenuated oral polio vaccine (OPV) and BCG vaccine were provided after supplementation. Infants also receive diphtheria, pertussis, tetanus (TT), hepatitis B (HBV) and Haemophilus influenzae B vaccines (pentavalent combination) along with OPV at 6, 10 and 14. weeks of age. Infant thymus size, anthropometry, feeding practice and morbidity data were collected at regular interval. Infant blood samples were collected to determine T-cell-receptor excision circle (TREC), total, naïve and memory T cells and mucosal targeting lymphocytes including Treg cells. TT-, HBV-, BCG- and OPV-specific T cell blastogenic, cytokine and plasma cell antibody responses were also measured. In 16 mo enrollment period, 306 newborns, equal number of boys and girls, were enrolled. ~. 95% completed the 4-month follow-up period. Baseline characteristics are presented here. Anthropometry and immune assays with fresh blood samples were completed immediately while stored samples were analyzed in single batches at the end of the trial. Connecting different aspects of immunological data in early infancy will help elucidate immune competence for protecting infection.

Original languageEnglish (US)
Pages (from-to)269-279
Number of pages11
JournalContemporary Clinical Trials
Volume39
Issue number2
DOIs
StatePublished - Nov 1 2014

Fingerprint

Vitamin A
Newborn Infant
Poliomyelitis
Anthropometry
Vaccines
Tetanus
Mental Competency
Haemophilus Vaccines
BCG Vaccine
T-Lymphocytes
Poverty Areas
Diphtheria
Survival
Whooping Cough
Regulatory T-Lymphocytes
Mycobacterium bovis
T-Cell Antigen Receptor
Plasma Cells
Hepatitis B
Thymus Gland

Keywords

  • Infant immunity
  • Neonatal vitamin A supplementation
  • Randomized controlled clinical trial

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Medicine(all)

Cite this

The effect of newborn vitamin A supplementation on infant immune functions : Trial design, interventions, and baseline data. / Ahmad, Shaikh Meshbahuddin; Raqib, Rubhana; Qadri, Firdausi; Stephensen, Charles B.

In: Contemporary Clinical Trials, Vol. 39, No. 2, 01.11.2014, p. 269-279.

Research output: Contribution to journalArticle

Ahmad, Shaikh Meshbahuddin ; Raqib, Rubhana ; Qadri, Firdausi ; Stephensen, Charles B. / The effect of newborn vitamin A supplementation on infant immune functions : Trial design, interventions, and baseline data. In: Contemporary Clinical Trials. 2014 ; Vol. 39, No. 2. pp. 269-279.
@article{85b1e1791a9c43218c450d603413b350,
title = "The effect of newborn vitamin A supplementation on infant immune functions: Trial design, interventions, and baseline data",
abstract = "In recent years, neonatal vitamin A supplementation is considered as an essential infant-survival intervention but the evidence is not conclusive. This randomized controlled clinical trial was conducted to evaluate the effect of vitamin A on immune competence in early infancy. Results would provide a mechanistic basis for understanding the effect of this intervention on infant survival. Within 2. days of birth, infants born at one maternity clinic located in a poor slum area of Dhaka city were supplemented with either 50,000. IU vitamin A or placebo. Live attenuated oral polio vaccine (OPV) and BCG vaccine were provided after supplementation. Infants also receive diphtheria, pertussis, tetanus (TT), hepatitis B (HBV) and Haemophilus influenzae B vaccines (pentavalent combination) along with OPV at 6, 10 and 14. weeks of age. Infant thymus size, anthropometry, feeding practice and morbidity data were collected at regular interval. Infant blood samples were collected to determine T-cell-receptor excision circle (TREC), total, na{\"i}ve and memory T cells and mucosal targeting lymphocytes including Treg cells. TT-, HBV-, BCG- and OPV-specific T cell blastogenic, cytokine and plasma cell antibody responses were also measured. In 16 mo enrollment period, 306 newborns, equal number of boys and girls, were enrolled. ~. 95{\%} completed the 4-month follow-up period. Baseline characteristics are presented here. Anthropometry and immune assays with fresh blood samples were completed immediately while stored samples were analyzed in single batches at the end of the trial. Connecting different aspects of immunological data in early infancy will help elucidate immune competence for protecting infection.",
keywords = "Infant immunity, Neonatal vitamin A supplementation, Randomized controlled clinical trial",
author = "Ahmad, {Shaikh Meshbahuddin} and Rubhana Raqib and Firdausi Qadri and Stephensen, {Charles B.}",
year = "2014",
month = "11",
day = "1",
doi = "10.1016/j.cct.2014.09.004",
language = "English (US)",
volume = "39",
pages = "269--279",
journal = "Contemporary Clinical Trials",
issn = "1551-7144",
publisher = "Elsevier Inc.",
number = "2",

}

TY - JOUR

T1 - The effect of newborn vitamin A supplementation on infant immune functions

T2 - Trial design, interventions, and baseline data

AU - Ahmad, Shaikh Meshbahuddin

AU - Raqib, Rubhana

AU - Qadri, Firdausi

AU - Stephensen, Charles B.

PY - 2014/11/1

Y1 - 2014/11/1

N2 - In recent years, neonatal vitamin A supplementation is considered as an essential infant-survival intervention but the evidence is not conclusive. This randomized controlled clinical trial was conducted to evaluate the effect of vitamin A on immune competence in early infancy. Results would provide a mechanistic basis for understanding the effect of this intervention on infant survival. Within 2. days of birth, infants born at one maternity clinic located in a poor slum area of Dhaka city were supplemented with either 50,000. IU vitamin A or placebo. Live attenuated oral polio vaccine (OPV) and BCG vaccine were provided after supplementation. Infants also receive diphtheria, pertussis, tetanus (TT), hepatitis B (HBV) and Haemophilus influenzae B vaccines (pentavalent combination) along with OPV at 6, 10 and 14. weeks of age. Infant thymus size, anthropometry, feeding practice and morbidity data were collected at regular interval. Infant blood samples were collected to determine T-cell-receptor excision circle (TREC), total, naïve and memory T cells and mucosal targeting lymphocytes including Treg cells. TT-, HBV-, BCG- and OPV-specific T cell blastogenic, cytokine and plasma cell antibody responses were also measured. In 16 mo enrollment period, 306 newborns, equal number of boys and girls, were enrolled. ~. 95% completed the 4-month follow-up period. Baseline characteristics are presented here. Anthropometry and immune assays with fresh blood samples were completed immediately while stored samples were analyzed in single batches at the end of the trial. Connecting different aspects of immunological data in early infancy will help elucidate immune competence for protecting infection.

AB - In recent years, neonatal vitamin A supplementation is considered as an essential infant-survival intervention but the evidence is not conclusive. This randomized controlled clinical trial was conducted to evaluate the effect of vitamin A on immune competence in early infancy. Results would provide a mechanistic basis for understanding the effect of this intervention on infant survival. Within 2. days of birth, infants born at one maternity clinic located in a poor slum area of Dhaka city were supplemented with either 50,000. IU vitamin A or placebo. Live attenuated oral polio vaccine (OPV) and BCG vaccine were provided after supplementation. Infants also receive diphtheria, pertussis, tetanus (TT), hepatitis B (HBV) and Haemophilus influenzae B vaccines (pentavalent combination) along with OPV at 6, 10 and 14. weeks of age. Infant thymus size, anthropometry, feeding practice and morbidity data were collected at regular interval. Infant blood samples were collected to determine T-cell-receptor excision circle (TREC), total, naïve and memory T cells and mucosal targeting lymphocytes including Treg cells. TT-, HBV-, BCG- and OPV-specific T cell blastogenic, cytokine and plasma cell antibody responses were also measured. In 16 mo enrollment period, 306 newborns, equal number of boys and girls, were enrolled. ~. 95% completed the 4-month follow-up period. Baseline characteristics are presented here. Anthropometry and immune assays with fresh blood samples were completed immediately while stored samples were analyzed in single batches at the end of the trial. Connecting different aspects of immunological data in early infancy will help elucidate immune competence for protecting infection.

KW - Infant immunity

KW - Neonatal vitamin A supplementation

KW - Randomized controlled clinical trial

UR - http://www.scopus.com/inward/record.url?scp=84908048658&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84908048658&partnerID=8YFLogxK

U2 - 10.1016/j.cct.2014.09.004

DO - 10.1016/j.cct.2014.09.004

M3 - Article

VL - 39

SP - 269

EP - 279

JO - Contemporary Clinical Trials

JF - Contemporary Clinical Trials

SN - 1551-7144

IS - 2

ER -