The nutrition intervention will be a multi-micronutrient (MMN) fortified lipid-based supplement (Nutriset, Malauney, France). In addition to the MMN and polyunsaturated lipids (linoleic 4.9 g and α-linolenic 0.59 g), the composition includes dried skimmed milk, soybean and peanut extract, sugar, maltodextrin stabilizers, and emulsifiers. The specific preparation is a modification of Nutributter by iLiNS based at UC Davis for research use with pregnant and lactating women (LNS P&L). This preparation is currently in use in studies in Ghana and Malawi where it has had formal acceptability testing. The micronutrient content of the daily 20 g supplement to be administered in this trial (Table 1 ) is unchanged from the LNS P&L except for an increase in the Vitamin D to conform to a recent update in the recommendation by the Institute of Medicine [30 ], and to allow for potentially lower bioactivity of the ergo-calciferol form chosen for acceptability to vegetarian populations. The zinc content was reduced to a level close to the recommendation of the Institute of Medicine for pregnant women [31 ]. The LNS P&L is water-free and has a long shelf life of 18 mo at room temperature in hot, humid environments.
The intervention will be initiated in Arm 1 within 2 wk of enrollment to give time for baseline studies and in Arm 2 once participants in Stage 2 reach 12 wk gestation and have completed dietary assessments (if applicable), anthropometry measurements and biospecimen collection, and ultrasound exams. For each of these two arms, the intervention will be terminated at delivery.
Fourteen daily supplements will be provided biweekly in 20 g sachets with instructions to take one sachet per day. A rodent and water resistant plastic container will be provided to each participant for storage of the sachets. The supplement can be eaten as is or mixed in with other foods depending on the preference of the participant. A record will be maintained indicating if sachet is taken alone or with meals. Instructions will be given to the participant that although the supplement can be added to other foods before eating, it should not be added to foods while cooking.
The intervention will be initiated in Arm 1 within 2 wk of enrollment to give time for baseline studies and in Arm 2 once participants in Stage 2 reach 12 wk gestation and have completed dietary assessments (if applicable), anthropometry measurements and biospecimen collection, and ultrasound exams. For each of these two arms, the intervention will be terminated at delivery.
Fourteen daily supplements will be provided biweekly in 20 g sachets with instructions to take one sachet per day. A rodent and water resistant plastic container will be provided to each participant for storage of the sachets. The supplement can be eaten as is or mixed in with other foods depending on the preference of the participant. A record will be maintained indicating if sachet is taken alone or with meals. Instructions will be given to the participant that although the supplement can be added to other foods before eating, it should not be added to foods while cooking.
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