Anemia Clinical Trial
Official title:
Impact of Pre-Pregnancy Micronutrient Supplementation on Maternal and Child Outcomes
Verified date | July 2021 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study evaluates the efficacy of providing weekly iron-folate (IFA) supplements or Multiple Micronutrient (MM) supplements before pregnancy in increasing birth weight and duration of gestation as well as maternal and infant iron status.
Status | Completed |
Enrollment | 5011 |
Est. completion date | December 2019 |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 35 Years |
Eligibility | Inclusion Criteria: - 18-35 years old - Currently married - Currently living in one of the 10 communes and intends to live in the areas for 24 months following recruitment - 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 |
Country | Name | City | State |
---|---|---|---|
Vietnam | Thainguyen University of Medicine and Pharmacy | Hành Ph? Thái Nguyên | Thái Nguyên |
Lead Sponsor | Collaborator |
---|---|
Emory University | Micronutrient Initiative, The Mathile Institute for the Advancement of Human Nutrition |
Vietnam,
Nguyen PH, DiGirolamo AM, Gonzalez-Casanova I, Pham H, Hao W, Nguyen H, Truong TV, Nguyen S, Harding KB, Reinhart GA, Martorell R, Ramakrishnan U. Impact of preconceptional micronutrient supplementation on maternal mental health during pregnancy and postp — View Citation
Nguyen PH, Gonzalez-Casanova I, Young MF, Truong TV, Hoang H, Nguyen H, Nguyen S, DiGirolamo AM, Martorell R, Ramakrishnan U. Preconception Micronutrient Supplementation with Iron and Folic Acid Compared with Folic Acid Alone Affects Linear Growth and Fine Motor Development at 2 Years of Age: A Randomized Controlled Trial in Vietnam. J Nutr. 2017 Aug;147(8):1593-1601. doi: 10.3945/jn.117.250597. Epub 2017 Jun 14. — View Citation
Nguyen PH, Lowe AE, Martorell R, Nguyen H, Pham H, Nguyen S, Harding KB, Neufeld LM, Reinhart GA, Ramakrishnan U. Rationale, design, methodology and sample characteristics for the Vietnam pre-conceptual micronutrient supplementation trial (PRECONCEPT): a randomized controlled study. BMC Public Health. 2012 Oct 24;12:898. doi: 10.1186/1471-2458-12-898. — View Citation
Nguyen PH, Young M, Gonzalez-Casanova I, Pham HQ, Nguyen H, Truong TV, Nguyen SV, Harding KB, Reinhart GA, Martorell R, Ramakrishnan U. Impact of Preconception Micronutrient Supplementation on Anemia and Iron Status during Pregnancy and Postpartum: A Rand — View Citation
Ramakrishnan U, Nguyen PH, Gonzalez-Casanova I, Pham H, Hao W, Nguyen H, Truong TV, Nguyen S, Harding KB, Reinhart GA, Neufeld LM, Martorell R. Neither Preconceptional Weekly Multiple Micronutrient nor Iron-Folic Acid Supplements Affect Birth Size and Ges — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Birth Size | Infants' weight, length and head circumference will be measured as early as possible within 24 hours after birth using standard procedures. All measurements will be obtained in duplicate by the same data collector. Weight-for-age and length-for-age z scores will be calculated using the 2006 WHO reference data. | At birth | |
Primary | Gestational Age | Gestational age will be calculated based on the date of last menstrual period. This method has been shown to be reliable in previous work and we expect precise estimates since we will be visiting women weekly from baseline during the prepregnancy period and will exclude women who may be have delivered in the past 6 months. | At birth | |
Primary | Child growth | Length and weight will be measured at birth, 1, 3, 6, 9, 12, 15, 18, and 24 mo | From birth through 24 months | |
Primary | Child development | Child development will be measured using the Bayley Scales for Infant Development III at 12 and 24 mo and the Wechsler Intelligence Scale for Children at age 6-7 y | Up to 7 years post enrollment | |
Primary | Weight-for-age Z score (WAZ) | Weight-for-age Z score (WAZ) in offspring of women receiving only FA, offspring of women who receive weekly pre-pregnancy IFA, and offspring of women who receive weekly MM supplements | Up to 7 years post enrollment | |
Primary | Height-for-age Z score (HAZ) | Height-for-age Z score (HAZ) in offspring of women receiving only FA, offspring of women who receive weekly pre-pregnancy IFA, and offspring of women who receive weekly MM supplements | Up to 7 years post enrollment | |
Primary | Weight -for-Height Z (WHZ) or Body Mass Index Z score (BMIZ) | Weight -for-Height Z score (WHZ) or BMIZ in offspring of women receiving only FA, offspring of women who receive weekly pre-pregnancy IFA, and offspring of women who receive weekly MM supplements | Up to 7 years post enrollment | |
Primary | Body composition (Lean mass/fat free mass index) | Body composition (Lean mass/fat free mass index) in offspring of women receiving only FA, offspring of women who receive weekly pre-pregnancy IFA, and offspring of women who receive weekly MM supplements | Up to 7 years post enrollment | |
Secondary | Mothers' iron status | Venous blood samples (5 ml) will be collected from women at: baseline, the first prenatal visit and at 1 and 3 months post partum. Anemia will be defined as Hb value <12 g/L for non-pregnant women,and <11g/L for pregnant women and infants, and iron deficiency as serum ferritin <12 µg/L (93). | At baseline and 1 and 3 months post partum | |
Secondary | Infants' iron status | Infant iron status will be measured in cord blood samples (5 ml) obtained at delivery and at 3 months of age using a capillary blood sample (100 l) that will be obtained from a heel prick.
The hemoglobin concentration will be measured from a drop of blood using the HEMOCUE B- Hb photometer. The blood samples will then be centrifuged and serum samples will be aliquotted into microcuvettes and handled in the same way as described for mothers. Serum ferritin and transferrin receptor concentrations will be assayed using the ELISA method. |
1 and 3 months of age | |
Secondary | Maternal depression | Center for Epidemiological Studies Depression Scale (CES-D) and Edinburgh Postnatal Depression Scale (EPDS) | At baseline, during pregnancy, 3 months postpartum |
Status | Clinical Trial | Phase | |
---|---|---|---|
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