INDiGO - Improving Infant Neurodevelopment and Growth Outcomes with Micronutrients

Phase 3

• Conditions: Paediatrics

• Registration Number: PACTR202201552774601
• Lead Sponsor: Kings College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-26
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 1200

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 or Central Kiang until the infant is 12 months of age

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 or Fula

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified