Rationale, design, methodology and sample characteristics for the Vietnam pre-conceptual micronutrient supplementation trial (PRECONCEPT): a randomized controlled study
<p>Abstract</p> <p>Background</p> <p>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 w...
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BMC
2012-10-01
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| Series: | BMC Public Health |
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| Online Access: | http://www.biomedcentral.com/1471-2458/12/898 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Nguyen Phuong H |
| collection | DOAJ |
| description | <p>Abstract</p> <p>Background</p> <p>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.</p> <p>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.</p> <p>Methods/design</p> <p>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.</p> <p>Discussion</p> <p>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.</p> <p>Trial registration</p> <p>NCT01665378</p> |
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| language | English |
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| publishDate | 2012-10-01 |
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| spelling | doaj.art-3987410dc330427eaa2a3a18ab9c85872022-12-22T01:51:30ZengBMCBMC Public Health1471-24582012-10-0112189810.1186/1471-2458-12-898Rationale, design, methodology and sample characteristics for the Vietnam pre-conceptual micronutrient supplementation trial (PRECONCEPT): a randomized controlled studyNguyen Phuong HLowe Alyssa EMartorell ReynaldoNguyen HieuPham HoaNguyen SonHarding Kimberly BNeufeld Lynnette MReinhart Gregory ARamakrishnan Usha<p>Abstract</p> <p>Background</p> <p>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.</p> <p>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.</p> <p>Methods/design</p> <p>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.</p> <p>Discussion</p> <p>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.</p> <p>Trial registration</p> <p>NCT01665378</p>http://www.biomedcentral.com/1471-2458/12/898AnemiaBirth weightStratified randomized controlled trialSupplementsVietnamPreconcept |
| spellingShingle | 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 Rationale, design, methodology and sample characteristics for the Vietnam pre-conceptual micronutrient supplementation trial (PRECONCEPT): a randomized controlled study BMC Public Health Anemia Birth weight Stratified randomized controlled trial Supplements Vietnam Preconcept |
| 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 | Anemia Birth weight Stratified randomized controlled trial Supplements Vietnam Preconcept |
| url | http://www.biomedcentral.com/1471-2458/12/898 |
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