In East Asia and the Pacific regions, 33.6 million children are not fulfilling their developmental potential, [1] maternal under-nutrition ranges from 10% to 21% and maternal anaemia routinely exceeds  40%. [2-4]

The Supplementation with Multiple Micronutrients Intervention Trial (Summit) [5] compared consumption of multiple micronutrient supplements to the WHO recommendation of iron/folic acid (IFA) supplementation for pregnant and post-partum women. Conducted from 2001 to 2004, SUMMIT was a double blind cluster‐randomized trial that assessed the health of ~32,000 pregnant and post-partum women taking either IFA or MMN supplements.

In this 10-year follow-up, the Summit Institute of Development (SID) will assess the health and cognitive development of children whose mothers participated in the SUMMIT trial. This study will assess the intellectual, social, and physical capability of these children, who are now 9-12 years of age. Evidence of long‐term benefits of maternal MMN on child development would inform policy change, and current investments in community‐based maternal and infant health programs would support the deployment of maternal MMN supplementation in low‐resource settings.

SUMMIT randomly assigned ~300 midwives to distribute IFA or MMN supplements to ~30,000 pregnant women through government prenatal care services that were strengthened by training and community-based advocacy. Pregnant women at any gestational age received either MMN or IFA to be taken daily, from enrolment to 3 months post-partum.

The follow-up study will assess children of these mothers across a variety of domains including physical growth and health, behavioural and emotional status, fine motor skills, educational attainment, general intellectual ability, executive function, activity levels and memory. It will also determine the key effect modifiers of demographics, child environment, and socio‐economic status, anaemia and micro-nutrients. 3,300 children will be randomly selected to represent 3 cohorts: the overall original trial population, children whose mothers were undernourished, and children whose mothers were anaemic. As a result, this study will determine not only if multivitamins given to pregnant and breastfeeding women improve cognitive and physical development of their children, but if the benefits for children are greater in women who are either anaemic or malnourished. This will provide evidence for selective intervention, if needed.

Funders

Grand Challenges Canada

Tracking of participants

In 2000, the Summit Institute of Development established demographic surveillance of more than 700,000 women of reproductive age and successfully coordinated with local health services and communities to deploy nearly 500 field staff with a high level of skill in tracking patients, community outreach and health assessment.

Current policy landscape in Indonesia and elsewhere

Current policy is to provide as many as 90 IFA supplements to each pregnant woman during antenatal care, and this system has been implemented in many other developing countries. Thus, through this routine government health system, MMN supplementation is a very feasible intervention for wide implementation in low‐resource settings.

The intervention is being advocated for Provincial and National scale-up. We have also discovered how synergies with the home environment and other prenatal and early childhood factors affect long term child growth and cognitive development.  This has led to other interventions to further improve child development.

SUMMIT was a double-blind, cluster-randomised trial. ~32,000 mothers were visited at home by a SUMMIT maternal data collector to obtain information within 3 days of enrollment (baseline), and at 36 weeks of gestational age, within 1 week after delivery, and at 12 weeks post-partum. The primary outcome assessed was early infant mortality, and secondary outcomes were neonatal mortality, fetal loss (abortions and stillbirths), and low birthweight. [5] There was an additional follow-up at pre-school age (~3.5 years).

Because SUMMIT found the benefit of MMN to be greater for certain groups of women, children representing these groups (overall population, maternal undernourishment and/or maternal anemia) will be assessed. Differences between children whose mothers took MMN or IFA across these groups will be estimated in mixed-effects models. The following core outcomes/concepts will be assessed:

(1) cognitive ability, including general intellectual ability, memory, and executive function, (2) fine motor skills, (3) behavioural and emotional problems, (4) educational attainment, (5) activity levels, (6) physical growth and body composition, (7) relevant medical history, (8) assessment of the child’s environment, (9) socio‐economic status, and (10) participant demographic information.

Where possible, tests have been selected that have previously been found to be sensitive to nutrition during gestation and infancy in this setting and/or are underpinned by plausible mechanisms, or have been successfully adapted by the project team or others to low‐resource settings.

Maternal MMN supplementation had beneficial effects for infants and children, especially in undernourished and anaemic women: [5]

• 18% reduction in early infant mortality in children born to women receiving MMN, with greater impact in children of mothers who were undernourished (25% reduction in mortality) or were anaemic (38% reduction in mortality).
• 30% reduction in post-neonatal mortality from 29 to 90 days after birth in children born to women receiving MMN.
• Improved child cognition at 42 months of age in children whose mothers had been undernourished or anaemic and were receiving MMN.
• At 3.5 years of age, children whose mothers received MMN had greater motor and cognitive ability than those who received IFA, equivalent to an advantage of two months of age. The effect was greater for children of undernourished and anaemic mothers, whose children had motor and cognitive advantages equivalent to four to five months of age.

The follow-up study is expected to demonstrate the long-term benefits, if any, associated with maternal MMN on child development.

1. Grantham‐McGregor S., et al. (2007) Developmental potential in the first 5 years for children in developing countries. Lancet 2007;369:60‐70.
2. Black RE, et al. (2008) Maternal and child undernutrition: global and regional exposures and health consequences. Lancet 2008;371:243‐60.
3. Balarajan Y. et al. (2011) Anaemia in low‐income and middleincome countries. Lancet.
4. McLean E. et al. (1993-2005) Worldwide prevalence of anaemia, WHO Vitamin and Mineral Nutrition Information System. Public health nutrition 2009;12:444‐54.
5. SUMMIT Study Group (2008). Effect of maternal multiple micronutrient supplementation on fetal loss and infant death in Indonesia: a double-blind cluster-randomised trial. Lancet, 371: 215-227.