Dewey 2011

Trial name or title	ILINS‐DYAD ‐ Ghana population. Protocol identifier: NCT00970866. Dewey 2011 title (abstract): Efficacy of Lipid‐Based Nutrient Supplements (LNS) for pregnant and lactating women and their Infants.
Methods	This study will be a community‐based, randomised controlled trial with 3 intervention groups.
Participants	Inclusion criteria At least 18 years of age. No more than 20 weeks of gestation. Given antenatal cards of the Ghana Health Service. Completed the initial routine antenatal examination at the clinics. HIV negative or status unknown (as from the antenatal card). Free from chronic disease, e.g. malignancy requiring frequent medical attention (as from the antenatal card). Residing in the Manya Krobo or Yilo Krobo district. Prepared to sign an informed consent. Living in the area throughout the duration of the study. Acceptance of home visitors. Exclusion criteria Known asthmatic or history of allergy towards peanut or milk products. Concurrent participation in another clinical trial. Severe illness warranting hospital referral.
Interventions	1. Dietary supplement: iron and folic acid (IFA): pregnant women will receive 1 (1) iron (60 mg) and folic acid (400 mcg) (IFA) tablet daily during pregnancy, and a tablet containing calcium (Ca) only (akin to a placebo) during lactation; there will be no supplementation for infants born to the women. The Fe/FA tablets will be taken each day with water after meals. 2. Dietary supplement: multiple micronutrient (MMN) group. Pregnant women will receive 1 (1) multiple‐micronutrient tablet daily during pregnancy and the first 6 months of lactation; there will be no supplementation for infants born to the women. The MMN tablets will be taken each day with water after meals. 3. Dietary supplement: lipid‐based nutrient supplements (LNS) group. Pregnant women will receive 20 g of LNS‐P&L daily during pregnancy and the first 6 months of lactation, whilst infants born to the women will receive 20 g of LNS‐20 g daily from 6 to 18 months of age.
Outcomes	Primary outcome is child length at birth, length‐for‐age Z‐score (LAZ, based on WHO 2006 growth standards) at 18 months of age. Secondary outcomes include the following. i. Maternal Anthropometric status (weight, BMI, mid‐upper arm circumference and subscapular skin‐fold thickness) at ˜ 36 wk gestation and at 6, 12, and 18 months postpartum. Pregnancy outcomes (birthweight, gestational age). Anemia, micronutrient (iron, vitamin A, B‐vitamins, zinc) and EFA status, and malarial antigen at ˜ 36 wk gestation and 6 mo postpartum. Total plasma cholesterol at ˜ 36 wk gestation. Blood pressure and urinary iodine, isoprostane (marker of oxidative stress) and 8‐hydroxy‐2'deoxyguanosine (8‐OHdG) (marker of DNA damage) at 36 wk gestation. Breast milk composition (EFA, vitamin A, B‐vitamins, iodine) at 6 mo postpartum. Depressive symptoms (which may be related to EFA status) at 6 mo postpartum. ii. Child Anthropometric status (weight, length, head circumference and mid‐upper arm circumference) at birth and 3, 6, 12 and 18 mo. Anaemia, micronutrient (iron, vitamin A, B‐vitamins, iodine) and EFA status, and malarial antigen at 6 and 18 months. Morbidity between 6 and 18 months. Child feeding practices and maternal report of child sleep patterns at 6, 12 and 18 months. Energy intake from complementary foods at 9 and 15 months. Antibody response to measles vaccination at 12 months. Achievement of 5 motor milestones (sitting without support, standing alone, walking with assistance, walking alone and running) and 4 other developmental milestones (pronouncing single words like mama or dada, waving goodbye, eating by self, drinking from a cup) from 0 to 18 months. Neuro‐behavioural development at 18 months of age.
Starting date	November 2009.
Contact information	Kathryn G Dewey, UC Davis
Notes	Sample size = 864. For the 2015 update of this review, we identified 3 further reports related to the ILINS‐DYAD Ghana trial: Adu‐Afarwuah 2013, Adu‐Afarwuah 2014 and Oaks 2014. These reports are abstracts; the full report of pregnancy outcome data has not yet been published.