Rationale, design, methodology and sample characteristics for the Vietnam pre-conceptual micronutrient supplementation trial (PRECONCEPT): A randomized controlled study

Low birth weight and maternal anemia remain intractable problems in many developing countries. The adequacy of the current strategy of providing iron-folic acid (IFA) supplements only during pregnancy has been questioned given many women enter pregnancy with poor iron stores, the substantial micronu...

Full description

Bibliographic Details
Main Authors: Nguyen, Phuong Hong, Lowe, Alyssa E., Martorell, Reynaldo, Nguyen, Hieu, Pham, Hoa, Nguyen, Son, Harding, Kimberly B., Neufeld, Lynnette M., Reinhart, Gregory A., Ramakrishnan, Usha
Format: Journal Article
Language:Inglés
Published: Springer 2012
Subjects:
Online Access:https://hdl.handle.net/10568/153243
_version_ 1855540616568504320
author Nguyen, Phuong Hong
Lowe, Alyssa E.
Martorell, Reynaldo
Nguyen, Hieu
Pham, Hoa
Nguyen, Son
Harding, Kimberly B.
Neufeld, Lynnette M.
Reinhart, Gregory A.
Ramakrishnan, Usha
author_browse Harding, Kimberly B.
Lowe, Alyssa E.
Martorell, Reynaldo
Neufeld, Lynnette M.
Nguyen, Hieu
Nguyen, Phuong Hong
Nguyen, Son
Pham, Hoa
Ramakrishnan, Usha
Reinhart, Gregory A.
author_facet Nguyen, Phuong Hong
Lowe, Alyssa E.
Martorell, Reynaldo
Nguyen, Hieu
Pham, Hoa
Nguyen, Son
Harding, Kimberly B.
Neufeld, Lynnette M.
Reinhart, Gregory A.
Ramakrishnan, Usha
author_sort Nguyen, Phuong Hong
collection Repository of Agricultural Research Outputs (CGSpace)
description Low birth weight and maternal anemia remain intractable problems in many developing countries. The adequacy of the current strategy of providing iron-folic acid (IFA) supplements only during pregnancy has been questioned given many women enter pregnancy with poor iron stores, the substantial micronutrient demand by maternal and fetal tissues, and programmatic issues related to timing and coverage of prenatal care. Weekly IFA supplementation for women of reproductive age (WRA) improves iron status and reduces the burden of anemia in the short term, but few studies have evaluated subsequent pregnancy and birth outcomes.The Preconcept trial aims to determine whether pre-pregnancy weekly IFA or multiple micronutrient (MM) supplementation will improve birth outcomes and maternal and infant iron status compared to the current practice of prenatal IFA supplementation only. This paper provides an overview of study design, methodology and sample characteristics from baseline survey data and key lessons learned.We have recruited 5011 WRA in a double-blind stratified randomized controlled trial in rural Vietnam and randomly assigned them to receive weekly supplements containing either: 1) 2800 μg folic acid 2) 60 mg iron and 2800 μg folic acid or 3) MM. Women who become pregnant receive daily IFA, and are being followed through pregnancy, delivery, and up to three months post-partum. Study outcomes include birth outcomes and maternal and infant iron status. Data are being collected on household characteristics, maternal diet and mental health, anthropometry, infant feeding practices, morbidity and compliance.The study is timely and responds to the WHO Global Expert Consultation which identified the need to evaluate the long term benefits of weekly IFA and MM supplementation in WRA. Findings will generate new information to help guide policy and programs designed to reduce the burden of anemia in women and children and improve maternal and child health outcomes in resource poor settings.NCT01665378.
format Journal Article
id CGSpace153243
institution CGIAR Consortium
language Inglés
publishDate 2012
publishDateRange 2012
publishDateSort 2012
publisher Springer
publisherStr Springer
record_format dspace
spelling CGSpace1532432025-09-25T13:01:45Z Rationale, design, methodology and sample characteristics for the Vietnam pre-conceptual micronutrient supplementation trial (PRECONCEPT): A randomized controlled study Nguyen, Phuong Hong Lowe, Alyssa E. Martorell, Reynaldo Nguyen, Hieu Pham, Hoa Nguyen, Son Harding, Kimberly B. Neufeld, Lynnette M. Reinhart, Gregory A. Ramakrishnan, Usha anaemia birth weight supplements randomized controlled trial Low birth weight and maternal anemia remain intractable problems in many developing countries. The adequacy of the current strategy of providing iron-folic acid (IFA) supplements only during pregnancy has been questioned given many women enter pregnancy with poor iron stores, the substantial micronutrient demand by maternal and fetal tissues, and programmatic issues related to timing and coverage of prenatal care. Weekly IFA supplementation for women of reproductive age (WRA) improves iron status and reduces the burden of anemia in the short term, but few studies have evaluated subsequent pregnancy and birth outcomes.The Preconcept trial aims to determine whether pre-pregnancy weekly IFA or multiple micronutrient (MM) supplementation will improve birth outcomes and maternal and infant iron status compared to the current practice of prenatal IFA supplementation only. This paper provides an overview of study design, methodology and sample characteristics from baseline survey data and key lessons learned.We have recruited 5011 WRA in a double-blind stratified randomized controlled trial in rural Vietnam and randomly assigned them to receive weekly supplements containing either: 1) 2800 μg folic acid 2) 60 mg iron and 2800 μg folic acid or 3) MM. Women who become pregnant receive daily IFA, and are being followed through pregnancy, delivery, and up to three months post-partum. Study outcomes include birth outcomes and maternal and infant iron status. Data are being collected on household characteristics, maternal diet and mental health, anthropometry, infant feeding practices, morbidity and compliance.The study is timely and responds to the WHO Global Expert Consultation which identified the need to evaluate the long term benefits of weekly IFA and MM supplementation in WRA. Findings will generate new information to help guide policy and programs designed to reduce the burden of anemia in women and children and improve maternal and child health outcomes in resource poor settings.NCT01665378. 2012-12 2024-10-01T13:55:50Z 2024-10-01T13:55:50Z Journal Article https://hdl.handle.net/10568/153243 en Open Access Springer Nguyen, Phuong H.; Lowe, Alyssa E.; Martorell, Reynaldo; Nguyen, Hieu; Pham, Hoa; Nguyen, Son; Harding, Kimberly B.; Neufeld, Lynnette M.; Reinhart, Gregory A.; Ramakrishnan, Usha 2012. Rationale, design, methodology and sample characteristics for the Vietnam pre-conceptual micronutrient supplementation trial (PRECONCEPT): A randomized controlled study. BMC Public Health 12: 898
spellingShingle anaemia
birth weight
supplements
randomized controlled trial
Nguyen, Phuong Hong
Lowe, Alyssa E.
Martorell, Reynaldo
Nguyen, Hieu
Pham, Hoa
Nguyen, Son
Harding, Kimberly B.
Neufeld, Lynnette M.
Reinhart, Gregory A.
Ramakrishnan, Usha
Rationale, design, methodology and sample characteristics for the Vietnam pre-conceptual micronutrient supplementation trial (PRECONCEPT): A randomized controlled study
title Rationale, design, methodology and sample characteristics for the Vietnam pre-conceptual micronutrient supplementation trial (PRECONCEPT): A randomized controlled study
title_full Rationale, design, methodology and sample characteristics for the Vietnam pre-conceptual micronutrient supplementation trial (PRECONCEPT): A randomized controlled study
title_fullStr Rationale, design, methodology and sample characteristics for the Vietnam pre-conceptual micronutrient supplementation trial (PRECONCEPT): A randomized controlled study
title_full_unstemmed Rationale, design, methodology and sample characteristics for the Vietnam pre-conceptual micronutrient supplementation trial (PRECONCEPT): A randomized controlled study
title_short Rationale, design, methodology and sample characteristics for the Vietnam pre-conceptual micronutrient supplementation trial (PRECONCEPT): A randomized controlled study
title_sort rationale design methodology and sample characteristics for the vietnam pre conceptual micronutrient supplementation trial preconcept a randomized controlled study
topic anaemia
birth weight
supplements
randomized controlled trial
url https://hdl.handle.net/10568/153243
work_keys_str_mv AT nguyenphuonghong rationaledesignmethodologyandsamplecharacteristicsforthevietnampreconceptualmicronutrientsupplementationtrialpreconceptarandomizedcontrolledstudy
AT lowealyssae rationaledesignmethodologyandsamplecharacteristicsforthevietnampreconceptualmicronutrientsupplementationtrialpreconceptarandomizedcontrolledstudy
AT martorellreynaldo rationaledesignmethodologyandsamplecharacteristicsforthevietnampreconceptualmicronutrientsupplementationtrialpreconceptarandomizedcontrolledstudy
AT nguyenhieu rationaledesignmethodologyandsamplecharacteristicsforthevietnampreconceptualmicronutrientsupplementationtrialpreconceptarandomizedcontrolledstudy
AT phamhoa rationaledesignmethodologyandsamplecharacteristicsforthevietnampreconceptualmicronutrientsupplementationtrialpreconceptarandomizedcontrolledstudy
AT nguyenson rationaledesignmethodologyandsamplecharacteristicsforthevietnampreconceptualmicronutrientsupplementationtrialpreconceptarandomizedcontrolledstudy
AT hardingkimberlyb rationaledesignmethodologyandsamplecharacteristicsforthevietnampreconceptualmicronutrientsupplementationtrialpreconceptarandomizedcontrolledstudy
AT neufeldlynnettem rationaledesignmethodologyandsamplecharacteristicsforthevietnampreconceptualmicronutrientsupplementationtrialpreconceptarandomizedcontrolledstudy
AT reinhartgregorya rationaledesignmethodologyandsamplecharacteristicsforthevietnampreconceptualmicronutrientsupplementationtrialpreconceptarandomizedcontrolledstudy
AT ramakrishnanusha rationaledesignmethodologyandsamplecharacteristicsforthevietnampreconceptualmicronutrientsupplementationtrialpreconceptarandomizedcontrolledstudy