A Novel Nano-iron Supplement to Safely Combat Iron Deficiency and Anaemia in Young Children: a Doubleblind Randomised Controlled Trial

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02941081
• Date of registration: 14/10/2016
• Prospective Registration: Yes
• Primary sponsor: London School of Hygiene and Tropical Medicine
• Public title: A Novel Nano-iron Supplement to Safely Combat Iron Deficiency and Anaemia in Young Children: a Doubleblind Randomised Controlled Trial IHAT-Gut
• Scientific title: A Novel Nano-iron Supplement (IHAT) to Safely Combat Iron Deficiency and Anaemia (IDA) in Young Children: a Doubleblind Randomised Controlled Trial
• Date of first enrolment: January 8, 2018
• Target sample size: 645
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02941081
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Gambia

Contacts

• Name: Dora Pereira, PhD
• Affiliation: Cambridge University, UK

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age 6-35 mo.

- Free of malaria (RDT negative)

- HAZ, WAZ, WHZ >-3 SD

- IDA defined as 7= Hb <11 g/dl AND ferritin<30 µg/L

- Resident in the study area (and planning to remain in the study area for the duration
of the trial)

- Ability and willingness to comply with the study protocol (daily intake of supplement
and daily study visits with weekly finger prick)

- Informed consent given by parent or guardian

Exclusion Criteria:

- Congenital disorders

- Chronic disease

- Currently participating in another study

- Currently taking iron supplements/multiple micronutrient supplements

- Currently experiencing moderate-severe diarrhoea, defined as those diarrhoea episodes
where (i) the child passes more than 5 loose or watery stools per day, (ii) there is
blood in the stool (dysentery), or (iii) the child shows signs of clinical dehydration
(assessed by the study nurse based on physical signs such as little or no urination,
sunken eyes, and skin that lacks its normal elasticity), will usually require
treatment (including ORS)



Age minimum: 6 Months
Age maximum: 35 Months
Gender: All

Health Condition(s) or Problem(s) studied

Iron Deficiency, Anaemia in Children

Intervention(s)

Dietary Supplement: IHAT

Other: Placebo

Dietary Supplement: Ferrous Sulphate

Primary Outcome(s)

incidence density' of moderate-severe diarrhea episodes [Time Frame: over 12 weeks]

proportion of children with iron deficiency [Time Frame: at 12 weeks]

period prevalence of moderate-severe diarrhoea [Time Frame: over 12 weeks]

Proportion of children with anaemia [Time Frame: at 12 weeks]

Secondary Outcome(s)

Ratio of enterobacteria/(bifidobacteria+lactobacilli) abundances [Time Frame: at baseline, 4 weeks and 12 weeks]

Serum non-transferrin bound iron [Time Frame: baseline day 1, day 15 and day 85]

Serum C-reactive protein and Alpha-1-acid glycoprotein [Time Frame: baseline day 1, day 15 and day 85]

Serum hepcidin [Time Frame: baseline 1day 1, day 15 and day 85]

Longitudinal prevalence of moderate-severe diarrhoea [Time Frame: over 12 weeks]

Proportion of children with enteric pathogens [Time Frame: at baseline, 4 weeks and 12 weeks]

hospitalisation events [Time Frame: over 12 weeks period]

Transferrin saturation [Time Frame: baseline5day 1, day 14 and day 85]

Alpha diversity and beta diversity of the faecal microbiome [Time Frame: at baseline, 4 weeks and 12 weeks]

Proportion of children with episodes of respiratory tract infections and malaria [Time Frame: over 12 weeks]

Gut inflammation [Time Frame: baseline day 1, day 15 and day 85]

Incidence density of 'bloody' diarrhea per month [Time Frame: per month]

Secondary ID(s)

SCC 1489

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Cambridge

Wellcome Trust

King's College London

MRC UK Biostatistics Unit

National Nutrition Agency (NaNa), The Gambia