Improving Infant Neurocognitive Development and Growth Outcomes with Micronutrients (INDiGO)

King's College London0 sites600 target enrollmentJuly 9, 2021

Overview

No summary available.

Registry

who.int

Start Date

July 9, 2021

End Date

March 31, 2026

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\. Pregnant women aged 18\-49 years
•2\. Singleton pregnancy at \<20 weeks gestation at initial pregnancy confirmation
•3\. Healthy, with no evidence of current severe anaemia (haemoglobin \>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

•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