Impact of Pre-pregnancy Micronutrient Supplementation on Maternal and Child Outcomes
This trial is active, not recruiting.
|Conditions||anemia, intrauterine growth retardation, preterm delivery, iron deficiency|
|Treatments||multiple micronutrient, iron and folic acid, folic acid|
|Start date||October 2011|
|End date||September 2014|
|Trial size||5011 participants|
|Trial identifier||NCT01665378, 10-1196-UEMORY-01, IRB00051384|
Low birth weight and anemia remain intractable problems in many developing countries despite considerable efforts to address them. Intervening with just prenatal iron-folate (IFA) supplements may not be the best approach given the substantial demands for iron by maternal and fetal tissues. Therefore, there is an urgent need to evaluate the additional contribution of prepregnancy interventions. We propose a double blind randomized controlled trial in rural Vietnam to evaluate the efficacy of weekly pre- pregnancy IFA or Multiple Micronutrient (MM) supplements on birth outcomes and maternal and infant iron status compared to providing only prenatal IFA supplements. This project is a collaborative effort between Emory University, USA and Thainguyen University of Medicine and Pharmacy, Vietnam. Eligible and willing women of reproductive age (WRA) will be assigned randomly to one of the following 3 groups of pre-pregnancy weekly supplementation: 1) FA (control) 2) IFA and 3) MM. All women will receive daily IFA when pregnant. We will recruit ~ 5000 WRA to obtain a sample of at least 1650 mother-infant pairs, which, at 90% power, will allow us to detect differences of ~ 60 g in birth weight between any two groups. Data on obstetric history, socio-demographic status, iron status, anthropometry and dietary intakes will be obtained at baseline. Key outcome measures will be 1) offspring's size and gestational age at birth 2) offspring's iron status at birth and 3 months of age and 3) maternal iron status at the beginning of pregnancy, 1 and 3 months post-partum. Intention to treat approach will be used to compare the various intervention groups. This study is timely and responds to the WHO Global Expert Consultation (2007) which identified the need to evaluate the long term benefits of weekly IFA and MM supplementation in WRA. The findings will provide the necessary evidence to policy makers to recommend weekly MM or IFA supplements to WRA to improve birth outcomes. The central hypothesis is that pre-pregnancy weekly IFA or MM supplementation followed by prenatal IFA and MM supplementation respectively, will improve birth outcomes as well as maternal and infant iron status compared to current practice of providing only prenatal IFA supplements. This hypothesis will be tested by conducting a randomized double-blinded placebo-controlled trial in Vietnam.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
time frame: At birth
time frame: At birth
Mothers' iron status
time frame: At baseline and 1 and 3 months post partum
Infants' iron status
time frame: 1 and 3 months of age
time frame: At baseline, during pregnancy, 3 months postpartum
Female participants from 18 years up to 35 years old.
Inclusion Criteria: - 18-35 years old - Currently married - Intends to live in the study area for the next 24 months - Plans to have children in the next year - Agrees to participate with informed consent Exclusion Criteria: - Currently pregnant - Delivered in the previous six months - Regularly consumed IFA or MM supplements in the past 2 months - Severe anemia (Hb < 7 g/L) - History of high risk pregnancy including abruptio placenta, placenta previa, gestational diabetes, pregnancy induced hypertension, coagulation disorders, thrombocytopenia or chronic vascular, renal or systemic disease and drug use - Chronic hematological diseases, hereditary defects of red cells or hemoglobin
|Official title||Impact of Pre-Pregnancy Micronutrient Supplementation on Maternal and Child Outcomes|
|Principal investigator||Usha Ramakrishnan, PhD|
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