Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202201552774601 Date of Approval: 21/01/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title INDiGO - Improving Infant Neurodevelopment and Growth Outcomes with Micronutrients
Official scientific title Micronutrient interventions to improve infant neurocognitive development and growth in early infancy
Brief summary describing the background and objectives of the trial Undernutrition during the early years of life has a harmful and irreversible impact on child growth and cognitive development. Many of the interventions tested to improve outcomes across infancy have had disappointing or inconsistent impact, a common feature being the absence of any attempts to provide nutritional supplements to infants during the first six months. With increasing evidence of micronutrient deficiencies in this age group, alongside strong evidence that growth and developmental deficits begin before six months, a renewed focus on the micronutrient status of infants is required. INDiGO is a randomised efficacy trial of micronutrient supplementation to mothers (during pregnancy or pregnancy and lactation) and infants (birth to six months) in rural Gambia, where rates of micronutrient deficiencies are high. 600 pregnant women (<20 weeks gestation) will be enrolled into one of five trial arms and mothers and infants (1.200 participants in total; 600 mother-infant pairs) will be followed to 12 months post-partum. The primary outcome will be infant brain development at six months, with micronutrient status, growth and neurocognitive development to 12 months as secondary outcomes. This novel research will identify the most efficacious way of improving micronutrient status in infancy, and assess impact on infant developmental outcomes, providing an evidence base for future effectiveness trials and policy recommendations.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) INDiGO
Disease(s) or condition(s) being studied Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 01/01/2022
Actual trial start date 05/05/2023
Anticipated date of last follow up 30/06/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 1200
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Multiple micronutrient Pregnancy and Lactation 1 capsule per day From 20 weeks of gestation until six months post-partum The multiple micronutrient supplement is the UNIMMAP formulation, a preparation of 15 micronutrients specifically designed for pregnancy, and as formulated by UNICEF/WHO/UNU. A single tablet provides the Recommended Dietary Allowance for each micronutrient. 360
Control Group Multiple micronutrient in pregnancy placebo in lactation 1 capsule per day Women will receive the same multiple micronutrient as the experimental group during pregnancy (20 weeks' gestation to delivery) and then from delivery until six months post-partum they will receive the placebo Multiple micronutrient (pregnancy, as above), maltodextrin capsule (placebo). 240 Placebo
Experimental Group Multiple micronutrient infants 5mL per day From day 8 until six-months post-partum A syrup developed for use in infants, containing the same 15 micronutrients given to women during pregnancy and lactation, but at levels appropriate for this age group. 240
Experimental Group Neuronutrients infants 5mL per day From day 8 until six-months post partum The same basic micronutrient formulation as used in the 'micronutrient' group, but with twice the dose and with the addition of choline (a nutrient essential for infant brain development known to be insufficient in this population). 120
Control Group Placebo infants 5mL per day From day 8 until six-months post-partum. Flavoured syrup 240 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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 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) Adult: 19 Year-44 Year,Infant: 0 Month-23 Month,New born: 0 Day-1 Month 0 Day(s) 39 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/05/2021 The Gambia Government MRC Joint Ethics Committee
Ethics Committee Address
Street address City Postal code Country
c/o MRC Unit The Gambia, Atlantic Boulevard Fajara POBox273 Gambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 22/07/2021 Kings College London Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Franklin Wilkins Building, 5.9 Waterloo Bridge Wing, Waterloo Road London SE1 9NH United Kingdom
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Infant neurocognitive development using functional near infrared spectroscopy (fNIRS). Six-months of infant age.
Secondary Outcome Maternal and infant micronutrient status. 1, 6 and 12 months post-partum.
Secondary Outcome Infant growth. Monthly from birth until 12 months of age.
Secondary Outcome Infant neurodevelopment. 1, 6 and 12 months of infant age.
Secondary Outcome Infant morbidity and feeding patterns. Weekly from birth until seven months of infant age and monthly thereafter until the infant reaches 12 months of age.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
MRC Unit The Gambia at the London School of Hygiene and Tropical Medicine Atlantic Boulevard Fajara Gambia
FUNDING SOURCES
Name of source Street address City Postal code Country
Wellcome Trust Gibbs Building 215 Euston Road London NW12BE United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kings College London St Thomas Hospital London SE1 7EH United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Dr Sarah Lloyd Fox Department of Psychology, Downing Site, University of Cambridge Cambridge CB2 3EB United Kingdom
Prof Clare Elwell Department of Medical Physics and Biomedical Engineering, Gower Street, University College London London WC1E 6BT United Kingdom
Prof Lindsay Allen USDA Western Human Nutrition Research Centre Davis CA 95616 United States of America
Dr Maria Andersson University Childrens Hospital Zurich Switzerland
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sophie Moore sophie.moore@kcl.ac.uk +4402071883639 10th Floor, North Wing, St Thomas Hospital
City Postal code Country Position/Affiliation
London SE1 7EH United Kingdom Reader
Role Name Email Phone Street address
Public Enquiries Mortala Ndow mortala.ndow@lshtm.ac.uk +2204495835 MRC Unit The Gambia
City Postal code Country Position/Affiliation
Fajara Gambia Project Manager
Role Name Email Phone Street address
Scientific Enquiries Andrew Prentice Andrew.Prentice@lshtm.ac.uk +2204495835 MRC Unit The Gambia
City Postal code Country Position/Affiliation
Fajara Gambia Head of Nutrition and Planetary Health Theme
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data that underlie the results reported in the primary trial publication, after deidentification (text, tables, figures, and appendices), will be available to researchers who provide a methodologically sound proposal and following the required regulatory approvals (e.g. ethical approval for data access). Informed Consent Form,Study Protocol Within 12 months of the publication of the primary trial paper. Deidentified data will be available, following approval via the required regulatory committees.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information