| Trial name or title | Effect of animal‐source food supplement prior to and during pregnancy on birthweight and prematurity in rural Vietnam. |
| Methods | Cluster‐randomised trial recruiting women from 29 communes in Vietnam. |
| Participants | Women recruited when registering for marriage. |
| Interventions | I) Food supplement 5 days/week from marriage to term (˜18 months). II) Food supplement 5 days/week from 16 weeks' gestation to term (˜5 months). III) Routine prenatal care. |
| Outcomes | The primary outcome is birthweight and the secondary outcome is the prevalence of prematurity. Other outcomes include maternal micronutrient status (iron, zinc, folic acid, vitamins A and B12), the incidence of infections; infant growth and infections from 0‐6 months of age are also assessed. Maternal data and information are measured at recruitment, 16, and 34 weeks' gestation. Infant anthropometric status is measured at birth, 1, 3, and 6 months. Infant gestational age is assessed at birth to determine the prevalence of pre‐term deliveries, and the mother’s activity or physical work during pregnancy is also determined. |
| Starting date | Not stated. |
| Contact information | N. Tu, Vietnam Nutrition Association, Hanoi, Vietnam. C. King, Children's Hospital Oakland Research Institute, Oakland, CA, USA. |
| Notes |
BMI: body mass index DHA: docosahexaenoic acid EPA: eicosapentaenoic acid Hb: haemoglobin IFA: iron and folic acid ITT: intention‐to‐treat LNS: lipid‐based nutrient supplement mcg: microgram MMN: multiple micronutrient RDA: recommended daily allowance SAE: serious adverse event