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

NCT02941081 | Completed Phase 2 DMC

• 1 other identifier: SCC 1489
• Study Type: interventional
• Target: 645
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

iron supplement

Outcome Measures

Primary Outcomes (4)

• proportion of children with iron deficiency

  Proportion of children at 12 weeks with iron deficiency (Cobas analyser). The choice of the marker to use to define iron deficiency will be made at the time of locking the data analysis plan and we will use the most up to date WHO recommendation at the time. But most likely it will be: ferritin \<12 mcg/liter, or \<30 mcg/liter in the presence of inflammation (CRP\>5), and (soluble transferrin receptor - sTfR)/log10 ferritin index \>2.

  at 12 weeks

• Proportion of children with anaemia

  Proportion of children at 12 weeks with anaemia (Medonic analyser). Anaemia is defined as haemoglobin \< 11 g/dl.

  at 12 weeks

• incidence density' of moderate-severe diarrhea episodes

  Incidence density of moderate-severe diarrhoea episodes over the 12 weeks (questionnaire/assessment by study nurse). Incidence density is defined as the number of new episodes of moderate-severe diarrhoea per child over the 12 weeks intervention

  over 12 weeks

• period prevalence of moderate-severe diarrhoea

  Period prevalence of moderate-severe diarrhea over the 12 weeks (questionnaire/assessment by study nurse). Period prevalence is defined as the proportion of children with at least one episode of moderate-severe diarrhea over the 12 weeks intervention

  over 12 weeks

Secondary Outcomes (12)

• Alpha diversity and beta diversity of the faecal microbiome

  at baseline, 4 weeks and 12 weeks

• hospitalisation events

  over 12 weeks period

• Ratio of enterobacteria/(bifidobacteria+lactobacilli) abundances

  at baseline, 4 weeks and 12 weeks

• Proportion of children with episodes of respiratory tract infections and malaria

  over 12 weeks

• Proportion of children with enteric pathogens

  at baseline, 4 weeks and 12 weeks

Study Arms (3)

IHAT

EXPERIMENTAL

IHAT arm: novel iron supplement - 1 dose/day single IMP containing IHAT (iron hydroxide adipate tartrate) powder bioequivalent to 12.5 mg elemental iron (i.e. 20 mg Fe taking into account IHAT's relative bioavailability to ferrous sulphate)

Dietary Supplement: IHAT

ferrous sulphate

ACTIVE COMPARATOR

Ferrous sulphate arm: clinical standard of oral iron supplementation - 1 dose/day single IMP containing ferrous sulphate (FeSO4 ) powder equivalent to 12.5 mg elemental iron

Dietary Supplement: Ferrous Sulphate

placebo

PLACEBO COMPARATOR

Placebo arm: 'no iron' arm - 1 dose/day containing saccharose powder

Other: Placebo

Interventions

IHAT DIETARY_SUPPLEMENT

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)

IHAT

Ferrous Sulphate DIETARY_SUPPLEMENT

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

ferrous sulphate

Placebo OTHER

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

placebo

Eligibility Criteria

• Age: 6 Months - 35 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• National Nutrition Agency (NaNa), The Gambia: collaborator
• Wellcome Trust: collaborator
• King's College London: collaborator
• University of Cambridge: collaborator
• MRC UK Biostatistics Unit: collaborator

Study Sites (1)

MRC Unit The Gambia

Basse Santa Su, Upper River Division, The Gambia

Location

Related Publications (3)

• Mohammed NI, Wason J, Mendy T, Nass SA, Ofordile O, Camara F, Baldeh B, Sanyang C, Jallow AT, Hossain I, Faria N, Powell JJ, Prentice AM, Pereira DIA. A novel nano-iron supplement versus standard treatment for iron deficiency anaemia in children 6-35 months (IHAT-GUT trial): a double-blind, randomised, placebo-controlled non-inferiority phase II trial in The Gambia. EClinicalMedicine. 2023 Feb 9;56:101853. doi: 10.1016/j.eclinm.2023.101853. eCollection 2023 Feb.

  PMID: 36880049 DERIVED

• de Goffau MC, Jallow AT, Sanyang C, Prentice AM, Meagher N, Price DJ, Revill PA, Parkhill J, Pereira DIA, Wagner J. Gut microbiomes from Gambian infants reveal the development of a non-industrialized Prevotella-based trophic network. Nat Microbiol. 2022 Jan;7(1):132-144. doi: 10.1038/s41564-021-01023-6. Epub 2021 Dec 31.

  PMID: 34972822 DERIVED

• Pereira DIA, Mohammed NI, Ofordile O, Camara F, Baldeh B, Mendy T, Sanyang C, Jallow AT, Hossain I, Wason J, Prentice AM. A novel nano-iron supplement to safely combat iron deficiency and anaemia in young children: The IHAT-GUT double-blind, randomised, placebo-controlled trial protocol. Gates Open Res. 2018 Oct 11;2:48. doi: 10.12688/gatesopenres.12866.2. eCollection 2018.

  PMID: 30569038 DERIVED

MeSH Terms

Conditions

Iron Deficiencies

Interventions

ferrous sulfate

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Dora Pereira, PhD

  Cambridge University, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2016
• First Posted: October 21, 2016
• Study Start: January 8, 2018
• Primary Completion: November 22, 2018
• Study Completion: May 28, 2019
• Last Updated: August 14, 2019

Record last verified: 2019-08

Locations

TH (1)