Paediatrics
Conditions
Interventions
Multiple micronutrient Pregnancy and Lactation
Multiple micronutrient in pregnancy placebo in lactation
Multiple micronutrient infants
Neuronutrients infants
Placebo infants
Sponsors
Kings College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Pregnancy < 20 weeks at initial pregnancy confirmation Singleton pregnancy Healthy, with no evidence of current severe anaemia Willingness to take a daily trial product (capsule) daily from 20 weeks of pregnancy until six-months post-partum and for their infant to receive a daily trial product (syrup drops) from Day 8 until 6 months of age Intention to remain resident in West, Central or East Kiang until the infant is 12 months of age
Exclusion criteria
Exclusion criteria: Pregnancy phase: Multiple pregnancy Pregnancy =20 weeks gestation Severe anaemia (<7g/dL) Any known history or evidence of chronic disease (including HIV, TB, non-pregnancy-induced-hypertension or diabetes). Women will be offered HIV Voluntary Counselling and Testing (as part of routine antenatal care) and, where positive, excluded from the trial Unwilling to avoid the ingestion of other micronutrient supplements during the study period If the primary language of the mother is not Mandinka, Fula or Wolof Post-partum / Infancy phase: Very or extremely preterm infants (< 32 weeks gestation at delivery) Very low birth weight infants (<1.5kg at delivery) Infants identified at any follow up point as having severe-acute malnutrition (weight-for-height z score of <-3SD) Non-breastfeeding mother-infant pairs Unwilling to avoid the ingestion of – or for their infant to avoid the ingestion of – other micronutrient supplements during the study period 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 neurocognitive development using functional near infrared spectroscopy (fNIRS). | — |
Secondary
| Measure | Time frame |
|---|---|
| Maternal and infant micronutrient status.;Infant growth.;Infant neurodevelopment.;Infant morbidity and feeding patterns. | — |
Countries
Gambia
Contacts
Public ContactMortala Ndow
Project Manager
Outcome results
None listed