2013 Annual Report
1a.Objectives (from AD-416):
This is an ancillary study to a randomized clinical trial of Delta Health Alliance (DHA) supplementation in overweight pregnant women. The objectices of this ancillary study are to: (1) evaluate pre-pregnancy body mass idex (BMI), pre-pregnancy iron status, perinatal weight gain (current weight - pre-pregnancy weight), inflammation, iron status, serum hepcidin concentrations, and dietary intake in overweight pregnant women at baseline (weeks 17-20 gestation); and assess relationships among these parameters; (2) evaluate perinatal weight grain, inflammation, iron status, and serum hepcidin concentrations in overweight pregnant women at 30 and 36 weeks gestation and at delivery; and assess for differences in parameter changes (from baseline) by supplementation group and relationships among these parameters; (3) evaluate neonatal inflammation, iron status, and serum hepcidin concentration (via cord blood), infant birth weight, and infant Activity, Pulse, Grimace, Appearance, and Respiration (APGAR) score at delivery; and assess for differences in these parameters by supplementation group and for relationships among the parameters; and (4) assess for relationships between maternal and neonatal inflammation, iron status, and serum hepcidin concentrations, and maternal perinatal weight gain at delivery.
1b.Approach (from AD-416):
This is an ancillary study to a randomized clinical trial of Delta Health Alliance (DHA) supplementation in overweight pregnant women. In the clinical trial, overweight pregnant women from Woman’s Hospital in Baton Rouge, LA, will be recruited, consented, and assessed at baseline (17-20 weeks gestation) for biochemical, anthropometric, dietary, and pre-pregnancy health and weight status. Participants will be randomized to DHA supplementation or olive oil placebo for the remainder of their pregnancy. Biochemical and dietary assessments will be repeated at 24, 30, and 36 months gestation and at delivery (no dietary assessment at this data collection point). Venous cord blood will be collected at delivery to determine infant biochemical parameters. Additionally, infant weight, gestational age, and Activity, Pulse, Grimace, Appearance, and Respiration (APGAR) score will be assessed at delivery.
Using existing samples from the clinical trial, the iron ancillary study will assess iron status (hemoglobin, ferritin, soluble transferrin receptor, and calculated total body iron), plasma hepcidin, erythropoietin, as well as dietary iron intake at baseline (17-20 weeks gestation), 24, 30 and 36 months gestation and at delivery (no dietary assessment). The ancillary study will also utilize maternal inflammatory, dietary, and anthropometric assessments collected as part of the clinical trial to assess treatment group outcomes. From existing venous cord blood samples collected in the clinical trial (dependent on availability), neonatal iron status (hemoglobin, ferritin, soluble transferrin receptor and calculated total body iron), hepcidin, and erythropoietin will be assessed. The ancillary study will also utilize infant inflammatory markers (IL-6 and CRP), gestational age, APGAR score, mode of delivery, birth weight collected in the clinical trial to compare treatment group outcomes.
Louisiana State University (LSU), in cooperation with ARS and the University of Illinois at Chicago (UIC) aims to address maternal overweight in Louisiana. Toward this effort, an ancillary study was added to the Louisiana Moms and Babies Study (LAMBS). LAMBS is a randomized clinical trial of docosahexaenoic acid (DHA) supplementation in overweight pregnant women residing in Louisiana. Institutional Review Board (IRB) approvals were received for the parent study, LAMBS, on March 12, 2013, from Woman’s Hospital in Baton Rouge, Louisiana, and on May 14, 2013, from Pennington Biomedical Research Center, Baton Rouge, Louisiana. IRB approval for the ancillary study is currently underway. An agreement for supply of the DHA capsules has been made with an industry partner. This company will produce, package, and randomize the capsules (DHA and placebo) for distribution in the study. The first shipment of capsules is scheduled for June 2013.