Iron Deficiency, Anaemia in ChildrenPhase 2IHAT-GutNCT02941081
A Novel Nano-iron Supplement to Safely Combat Iron Deficiency and Anaemia in Young Children: a Doubleblind Randomised Controlled Trial
A Phase 2 study testing IHAT and Ferrous Sulphate in people with Iron Deficiency, Anaemia in Children, run by London School of Hygiene and Tropical Medicine at 1 site in The Gambia.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 35 monthsHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency, Anaemia in Children
- What is being tested?
- IHAT and Ferrous Sulphate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 645 participants
- Where
- 1 siteThe Gambia
- Study dates
- 8 Jan 2018to 28 May 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 35 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Novel Nano-iron Supplement (IHAT) to Safely Combat Iron Deficiency and Anaemia (IDA) in Young Children: a Doubleblind Randomised Controlled Trial
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.
Read the detailed description
The primary objectives of this trial are: (i) show non-inferiority of IHAT compared to ferrous sulphate for efficacy (in terms of Hb and iron deficiency correction); (ii) show superiority of IHAT compared to ferrous sulphate in terms of moderate-severe diarrhoea (incidence and prevalence); (iii) show non-inferiority of IHAT compared to placebo in terms of prevalence of moderate-severe diarrhoea.
Secondary objectives are: (i) show that IHAT supplementation does not increase enteric pathogen burden; (ii) show that IHAT supplementation is non-detrimental to the gut microbiome; (iii) show that IHAT supplementation does not cause intestinal inflammation; (iv) describe the impact of IHAT supplementation on hospitalisation and morbidity; (v) determine the effect of IHAT supplementation on systemic inflammation; (vi) determine the effect of IHAT supplementation on systemic markers of iron handling.
To investigate the primary and secondary objectives the investigators will conduct a 3-arm, parallel, randomised, double-blind, placebo-controlled, phase 2, clinical trial.
Participants will be iron deficient anaemic young children living in rural communities in the North Bank of the Upper River Division in The Gambia.
The communities and health centres within the study catchment area (Wuli and Sandu districts) will be sensitised to the study. Young children will be identified using the immunisation records at the health centres. At screening, once mothers/guardians of the child have signed the informed consent form, the child will be physically examined by a study nurse and, if the child is considered as generally healthy, their height and weight will be measured and a finger prick blood sample will be collected for Hb and RDT testing. If z-scores are >-3, 7 ≤Hb< 11 g/dL and the RDT is negative, a small venous blood sample will be collected to confirm the Hb levels and determine serum ferritin. A total of 705 eligible children will be randomised into the 3 study arms (n=235 per arm).
In each study arm, the children will be supplemented daily for 12 weeks (84 days) with either placebo, ferrous sulphate or IHAT. Blood and stool samples will be collected at baseline (Day 1) and at day 15 and day 85 during the intervention period. Following the 12 weeks of intervention there will be an additional active follow-up period of 4 weeks without intervention.
Highly trained and experienced field workers will be visiting all children every day during the 12 weeks supplementation period in order to administer the iron supplements or placebo and on these occasions they will check on the children's general health and actively look for signs of malaria and co-infections. If a child shows signs of these infections, the field worker will refer to the study nurse who will perform adequate tests and the child will be offered the appropriate treatment/referral to the next health center. Three times per week, morbidity data (including questions regarding fever, diarrhoea, vomiting, cough, any other illness, appetite and any mediation taken and assessment of body temperature) will be captured. Every week children will be screened using a finger prick blood sample to determine their malaria and Hb status and children found with a positive RDT during the study will be further tested with a blood film and treated according to national guidelines. These visits will continue 4 weeks post intervention to follow-up on AE/SAEs. Any child where Hb falls below 7 g/dL during the follow-up study period will stop the study and will be referred to the next health centre for managemen
- Conditions
- Iron Deficiency, Anaemia in Children
- Being tested
- IHAT, Ferrous Sulphate, Placebo
- Keywords
- iron supplement
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IHATDietary 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)
Ferrous SulphateDietary supplement
1 dose/day single IMP containing FeSO4 powder equivalent to 12.5 mg Fe
PlaceboOther
1 dose/day containing a placebo powder (no-iron, 'sugar' compound)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: Dietary Supplement: Ferrous Sulphate |
| placebo | Placebo comparator | Placebo arm: 'no iron' arm - 1 dose/day containing saccharose powder Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: over 12 weeks
Secondary outcomes (12)
Alpha diversity and beta diversity of the faecal microbiome
Alpha diversity and beta diversity of the faecal microbiome at baseline, 4 weeks and 12 weeks data from MiSeq sequencing of faecal 16S rRNA)
Measured: at baseline, 4 weeks and 12 weeks
hospitalisation events
Number of new hospitalization events per child over the 12 weeks (questionnaire
Measured: over 12 weeks period
Ratio of enterobacteria/(bifidobacteria+lactobacilli) abundances
Ratio of enterobacteria/(bifidobacteria+lactobacilli) abundances in the faecal microbiome at baseline, 4 weeks and 12 weeks (data from MiSeq sequencing of faecal 16S rRNA)
Measured: at baseline, 4 weeks and 12 weeks
Proportion of children with episodes of respiratory tract infections and malaria
Proportion of children with episodes of respiratory tract infections and malaria over the 12 weeks (questionnaire)
Measured: over 12 weeks
Proportion of children with enteric pathogens
Proportion of children with enteric pathogens at baseline, 4 weeks and 12 weeks (targeted qPCR)
Measured: at baseline, 4 weeks and 12 weeks
Gut inflammation
Gut inflammation measured with faecal calprotectin (ELISA)
Measured: baseline day 1, day 15 and day 85
Longitudinal prevalence of moderate-severe diarrhoea
Longitudinal prevalence of moderate-severe diarrhoea (questionnaire/assessment by study nurse). Longitudinal prevalence is defined as the number of days a child has moderate-severe diarrhea over the 12 weeks intervention
Measured: over 12 weeks
Incidence density of 'bloody' diarrhea per month
Incidence density of 'bloody' diarrhea per month (questionnaire/assessment by study nurse). Defined as the number of diarrhea episodes with blood in the stool, as a sign of severe intestinal infection, per child-month of observation
Measured: per month
Serum C-reactive protein and Alpha-1-acid glycoprotein
Serum C-reactive protein and Alpha-1-acid glycoprotein (Cobas analyser). Markers of systemic inflammation
Measured: baseline day 1, day 15 and day 85
Serum hepcidin
Serum hepcidin (ELISA). Marker of systemic iron handling
Measured: baseline 1day 1, day 15 and day 85
Serum non-transferrin bound iron
Serum non-transferrin bound iron (flurescence chemical assay). Marker of systemic iron handling.
Measured: baseline day 1, day 15 and day 85
Transferrin saturation
Transferrin saturation (Cobas analyser). Marker of systemic iron handling
Measured: baseline5day 1, day 14 and day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study start8 Jan 2018
- Primary completion22 Nov 2018
- Study completion28 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Iron Deficiency, Anaemia in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 645 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Nutrition Agency (NaNa), The Gambia, Wellcome Trust, King's College London, University of Cambridge, MRC UK Biostatistics Unit
- Responsible party
- Sponsor
- Investigators
- Dora Pereira, PhD, Principal investigator, Cambridge University, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02941081
- Sponsor's protocol ID
- SCC 1489
- Acronym
- IHAT-Gut
- Status last verified
- Aug 2019
- First submitted
- 14 Oct 2016
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36880049de 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.
PubMed 34972822Pereira 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.
PubMed 30569038
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Nano-iron Supplement (IHAT) to Safely Combat Iron Deficiency and Anaemia (IDA) in Young Children: a Doubleblind Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02941081
- Acronym / sponsor ID
- IHAT-Gut / SCC 1489
- Conditions
- Iron Deficiency, Anaemia in Children
- Keywords
- iron supplement
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 645 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- National Nutrition Agency (NaNa), The Gambia, Wellcome Trust, King's College London, University of Cambridge, MRC UK Biostatistics Unit
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 22 Nov 2018 (actual)
- Study completion
- 28 May 2019 (actual)
- First posted
- 21 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary objectives of this trial are: (i) show non-inferiority of IHAT compared to ferrous sulphate for efficacy (in terms of Hb and iron deficiency correction); (ii) show superiority of IHAT compared to ferrous sulphate in terms of moderate-severe diarrhoea (incidence and prevalence); (iii) show non-inferiority of IHAT compared to placebo in terms of prevalence of moderate-severe diarrhoea.
Secondary objectives are: (i) show that IHAT supplementation does not increase enteric pathogen burden; (ii) show that IHAT supplementation is non-detrimental to the gut microbiome; (iii) show that IHAT supplementation does not cause intestinal inflammation; (iv) describe the impact of IHAT supplementation on hospitalisation and morbidity; (v) determine the effect of IHAT supplementation on systemic inflammation; (vi) determine the effect of IHAT supplementation on systemic markers of iron handling.
To investigate the primary and secondary objectives the investigators will conduct a 3-arm, parallel, randomised, double-blind, placebo-controlled, phase 2, clinical trial.
Participants will be iron deficient anaemic young children living in rural communities in the North Bank of the Upper River Division in The Gambia.
The communities and health centres within the study catchment area (Wuli and Sandu districts) will be sensitised to the study. Young children will be identified using the immunisation records at the health centres. At screening, once mothers/guardians of the child have signed the informed consent form, the child will be physically examined by a study nurse and, if the child is considered as generally healthy, their height and weight will be measured and a finger prick blood sample will be collected for Hb and RDT testing. If z-scores are >-3, 7 ≤Hb< 11 g/dL and the RDT is negative, a small venous blood sample will be collected to confirm the Hb levels and determine serum ferritin. A total of 705 eligible children will be randomised into the 3 study arms (n=235 per arm).
In each study arm, the children will be supplemented daily for 12 weeks (84 days) with either placebo, ferrous sulphate or IHAT. Blood and stool samples will be collected at baseline (Day 1) and at day 15 and day 85 during the intervention period. Following the 12 weeks of intervention there will be an additional active follow-up period of 4 weeks without intervention.
Highly trained and experienced field workers will be visiting all children every day during the 12 weeks supplementation period in order to administer the iron supplements or placebo and on these occasions they will check on the children's general health and actively look for signs of malaria and co-infections. If a child shows signs of these infections, the field worker will refer to the study nurse who will perform adequate tests and the child will be offered the appropriate treatment/referral to the next health center. Three times per week, morbidity data (including questions regarding fever, diarrhoea, vomiting, cough, any other illness, appetite and any mediation taken and assessment of body temperature) will be captured. Every week children will be screened using a finger prick blood sample to determine their malaria and Hb status and children found with a positive RDT during the study will be further tested with a blood film and treated according to national guidelines. These visits will continue 4 weeks post intervention to follow-up on AE/SAEs. Any child where Hb falls below 7 g/dL during the follow-up study period will stop the study and will be referred to the next health centre for managemen
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IHAT | Experimental | Dietary Supplement: IHATIHAT 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) |
| ferrous sulphate | Active comparator | Dietary Supplement: Ferrous SulphateFerrous 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 |
| placebo | Placebo comparator | Other: PlaceboPlacebo arm: 'no iron' arm - 1 dose/day containing saccharose powder |
Who may qualify
- Ages
- 6 to 35 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IHAT1 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 | IHAT |
| Ferrous Sulphate1 dose/day single IMP containing FeSO4 powder equivalent to 12.5 mg Fe | Dietary supplement | ferrous sulphate |
| Placebo1 dose/day containing a placebo powder (no-iron, 'sugar' compound) | Other | placebo |
Primary outcome
proportion of children with iron deficiency
Time frame: at 12 weeks
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.
Proportion of children with anaemia
Time frame: at 12 weeks
Proportion of children at 12 weeks with anaemia (Medonic analyser). Anaemia is defined as haemoglobin < 11 g/dl.
incidence density' of moderate-severe diarrhea episodes
Time frame: over 12 weeks
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
period prevalence of moderate-severe diarrhoea
Time frame: over 12 weeks
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
12 secondary outcomes
Alpha diversity and beta diversity of the faecal microbiome
Time frame: at baseline, 4 weeks and 12 weeks
hospitalisation events
Time frame: over 12 weeks period
Ratio of enterobacteria/(bifidobacteria+lactobacilli) abundances
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
Proportion of children with enteric pathogens
Time frame: at baseline, 4 weeks and 12 weeks
Gut inflammation
Time frame: baseline day 1, day 15 and day 85
Longitudinal prevalence of moderate-severe diarrhoea
Time frame: over 12 weeks
Incidence density of 'bloody' diarrhea per month
Time frame: per month
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
Serum non-transferrin bound iron
Time frame: baseline day 1, day 15 and day 85
Transferrin saturation
Time frame: baseline5day 1, day 14 and day 85
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Derived from this study: PubMed 36880049Mohammed 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.
- Derived from this study: PubMed 34972822de 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.
- Derived from this study: PubMed 30569038Pereira 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dora Pereira, PhD principal investigator
Cambridge University, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IHAT and Ferrous Sulphate in people with Iron Deficiency, Anaemia in Children, run by London School of Hygiene and Tropical Medicine at 1 site in The Gambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in The Gambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of children with iron deficiency (time frame: at 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02941081, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2019.