Infant neurocognitive development and growth Other
Conditions
Interventions
During pregnancy and lactation women will be randomised to receive a daily multiple micronutrient (MMN) supplement (capsule) or placebo. For the MMN intervention arms, the researchers will use the UNI
Arm 5 will receive a formulation identical in composition to the basic infant MMN formulation, but with twice the dose and with the addition of choline. Inclusion of this fifth ‘neuro-nutrient’ (NN) c
Sponsors
King's College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Pregnant women aged 18-49 years 2. Singleton pregnancy at 7 g/dl) 4. Willingness to take a daily trial product (capsule) daily from 20 weeks of pregnancy until 6 months post-partum and for their infant to receive a daily trial product (syrup drops) from Day 8 until 6 months of age
Exclusion criteria
Exclusion criteria: Pregnancy: 1. Multiple pregnancy 2. Pregnancy =20 weeks gestation 3. Severe anaemia (haemoglobin <7 g/dl) 4. Any history or evidence of chronic disease (including HIV, TB, hypertension) 5. Unwilling to avoid the ingestion of other micronutrient supplements during the study period Post-partum/infancy: 1. Very or extremely preterm infants (< 32 weeks gestation at delivery) 2. Very low birth weight infants (<1.5 kg at delivery) 3. Infants identified at any follow-up point as having severe-acute malnutrition (weight-for-height z score of <-3SD) 4. Non-breastfeeding mother-infant pairs 5. Unwilling to avoid the ingestion of – or for their infant to avoid the ingestion of – other micronutrient supplements during the study period 6. Any condition of the mother or infant that, in the opinion of the investigator, might compromise the safety or well-being of the participant or compromise adherence to protocol procedures (including the identification of severe neurodevelopmental conditions, such as cerebral palsy)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Infant neurodevelopment assessed using functional near-infrared spectroscopy (fNIRS) when infants are 6 months of age | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Infant micronutrient status (iron, iodine, choline, vitamin B12) measured by blood/urine analysis on samples collected at 1, 6 and 12 months of infant age 2. Growth measured by assessment of infant size (weight, length, mid-upper arm circumference, head circumference) at monthly visits from birth until 12 months of infant age 3. Neurocognitive development measured by a behavioural assessment (Mullen Scales of Early Learning) and measures of brain function using functional near-infrared spectroscopy (fNIRS) and eye-tracking technology at 1, 6 and 12 months of infant age | — |
Countries
Gambia
Outcome results
None listed