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

NCT02941081 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 645

Last updated 2019-08-14

No results posted yet for this study

Summary

This study aims to determine whether IHAT is non-inferior to ferrous sulphate at correcting iron deficiency and anaemia, and if IHAT does not increase diarrhoea risk in young children living in rural and resource-poor areas of the Gambia.

The study hypothesis is that IHAT will eliminate iron deficiency and improve haemoglobin levels in young children without increasing infectious diarrhoea or promoting inflammation in the gut.

Conditions

  • Iron Deficiency, Anaemia in Children

Interventions

DIETARY_SUPPLEMENT

IHAT

1 dose/day single IMP containing IHAT powder bioequivalent to 12.5 mg Fe (i.e. 20 mg Fe taking into account IHAT's relative bioavailability to FeSO4)

DIETARY_SUPPLEMENT

Ferrous Sulphate

1 dose/day single IMP containing FeSO4 powder equivalent to 12.5 mg Fe

OTHER

Placebo

1 dose/day containing a placebo powder (no-iron, 'sugar' compound)

Sponsors & Collaborators

  • National Nutrition Agency (NaNa), The Gambia

    collaborator UNKNOWN

  • Wellcome Trust

    collaborator OTHER

  • King's College London

    collaborator OTHER

  • University of Cambridge

    collaborator OTHER

  • MRC UK Biostatistics Unit

    collaborator UNKNOWN

  • London School of Hygiene and Tropical Medicine

    lead OTHER

Principal Investigators

  • Dora Pereira, PhD · Cambridge University, UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
35 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-08
Primary Completion
2018-11-22
Completion
2019-05-28

Countries

  • The Gambia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02941081 on ClinicalTrials.gov