AnemiaNCT03341338
Genes-in-Action - Hepcidin Regulation of Iron Supplementation
An observational study of Anemia, run by London School of Hygiene and Tropical Medicine at 1 site in The Gambia.
Trial summary
Anaemia continues to be one of the most common health problems affecting children and pregnant women in low-income countries. Nutritional iron deficiency is believed to be the main driver of anaemia, so mass iron supplementation and food fortification programs have been recommended by most public health organizations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anemia
- How many people
- 206 participants
- Where
- 1 siteThe Gambia
- Study dates
- 5 Sep 2016to 29 Apr 2019
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adult Gambians (aged >18 years) with available genotype data from a cohort of 3118 individuals
Who may be able to join
- Be healthy and over 18 years of age old.
- Have provided appropriate ethical consent for involvement in studies relating to genetics.
- Have available genotype data based on previous or ongoing genetic studies. Fasted (overnight)
Who cannot join
- Indication of infection/inflammation at the time of enrollment as determined by self-reporting, medical history or hematology (full blood count)
- Severe anemia (HGB<7 g/dL)
- Pregnant and lactating women
- Carrier of known genetic variants associated with iron metabolism (sickle trait, G6PD deficiency variants, HFE polymorphisms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Effects of Genetic Variations Within the Hepcidin Pathway Genes on Oral Iron Absorption Using a Genes-in-Action Study Design
Anaemia continues to be one of the most common health problems affecting children and pregnant women in low-income countries. Nutritional iron deficiency is believed to be the main driver of anaemia, so mass iron supplementation and food fortification programs have been recommended by most public health organizations. However, these interventions are frequently ineffective and new strategies are desperately needed.
Both anaemia and iron absorption are influenced by multiple factors, including nutritional status, infection, low grade inflammation and host genetics. The discovery of hepcidin, the master regulator of iron absorption and regulation has opened new avenues for investigation. Genome-wide association studies have identified several single nucleotide polymorphisms (SNPs) within hepcidin regulatory genes that are associated with altered iron status both in African populations.
The study aims to investigate the impact of genetic alterations in hepcidin regulation on oral iron absorption. A recall-by-genotype study will be conducted using an existing database of pre-genotype individuals in rural Gambia (West Kiang). This database comprise of data on >3000 Gambians, with Illumina HumanExome array data on 80K directly genotyped putative functional variants as well as imputation data on 20M variants.
Read the detailed description
Anaemia is a recalcitrant problem in global health, affecting particularly children and childbearing women in sub-Saharan Africa. Anaemia causes impaired growth and cognitive development in children, poor pregnancy outcomes including both maternal and perinatal mortality. Also, it is associated with poor economic growth due to its impact on physical activity.
Mass iron supplementation and food fortification are commonly used to combat anaemia in low- and middle-income countries. This due to the fact that the main driver of anaemia is thought to be nutritional iron deficiency. However, these programs have had little impact in sub-Saharan Africa and new strategies are desperately needed.
Low-cost oral iron tablets and micronutrient powders are routinely given to treat and prevent anaemia in both children and pregnant women. However, often these interventions are frequently ineffective, never very effective, and may even cause harm by increasing susceptibility to infections. Both the aetiology of anaemia and the efficacy of iron absorption are complex processes influenced by multiple factors, including nutritional status, infection and host genetics.
Hepcidin, a 25-amino acid liver-produced hormone is the master regulator of body iron status. Hepcidin controls plasma iron influx through its interaction with ferroportin - the only known cellular iron channel. Hepcidin's binding to ferroportin leads to the degradation and internalisation of the latter, thereby blocking iron traffic from macrophages, hepatocytes and duodenal enterocytes, into the plasma. Hepcidin secretion is dampened by hypoxia, erythroid drive and iron deficiency, to enable iron absorption, whereas, iron sufficiency/overload and infection enhances hepcidin transcription.
Hepcidin transcription is regulated by a number of signals and pathways. At the molecular level, the regulation of hepcidin expression is complex, but one of the key regulators is TMPRSS6 (transmembrane protease serine 6). TMPRSS6 (also called matriptase-2) is a type II transmembrane serine protease principally expressed in the liver. TMPRSS6 indirectly regulates hepcidin transcription, by interfering with the bone morphogenetic protein (BMP), hemojuvelin (HJV), and son of mothers against decapentaplegic homolog (SMAD) signalling pathway. TMPRSS6 decreases hepcidin transcription by cleaving hemojuvelin (HJV), thus, reducing BMP-SMAD signalling. Cleavage of membrane-bound HJV, the BMP receptor, by TMPRSS6 leads to BMP reduction, thereby decreasing BMP, resulting in hepcidin repression as BMP-HJV signalling is required for hepcidin transcription. TMPRSS6 is the main negative regulator of hepcidin expression and functional variants leas to iron-refractory iron deficiency anaemia (IRIDA).
Due to its central role in iron homeostasis, most inherited iron pathologies arise from genetic defects in genes encoding proteins that regulate hepcidin or in the hepcidin gene (HAMP) itself. Genetic variations that inactivate HAMP expression result in hepcidin deficiency, which has been implicated inherited iron-loading diseases such as hereditary hemochromatosis (HH). In contrast, genetic alteration that lead to elevated ristrictis iron availability. For instance, genetic defects that curtail the expression of TMPRSS6 results in elevated hepcidin, thereby causing anaemia that is resistant to oral iron supplementation, IRIDA.
This project aims to investigate the impact of functional single nucleotide polymorphisms (SNPs) in the genes within the hepcidin regulatory pathways that are known or proposed to predispose to low iron status. To begin with, the focus will be on three common SNPs within the TMPRSS6 gene, rs855791, rs4820268 and rs2235321, with minor allele frequencies (MAF) at 7, 27 and 44% in the study population. These SNPs were selected with reference to previous association and genome-wide association (GWA) studies. All three SNPs have been significantly associated with fall in plasma iron status biomarkers, including serum iron, haemoglobin concentrations, transferrin saturation, and a rise in hepcidin levels, as well as iron deficiency anaemia in both association and GWA studies.
The hypothesis is that risk alleles will cause a baseline increase in serum hepcidin levels and that individuals with these SNPs will absorb iron less effectively than those with the wild-type alleles. Subsequently, more functional or putative functional SNPs within the TMPRSS6 gene and other hepcidin/iron-related genes such as TF, SLC11A2, TFR2 will be investigated.
Several GWAS have to identified dozens of SNPs association associated with low iron status. Although these studies can detect phenotype-genotype associations, they fail to reveal functional and mechanism underlying genotype-phenotyoe relationships. For instance, this approach may be misleading due influence of variations in interim phenotypes, especially in relation to genetic predictors of infections. Thus, in order to overcome this limitation, the investigators will employ a recall-by-genotype paradigm the investigators termed 'Genes-in-Action' (GiA) to understand genotype-phenotype relationships and identify causal relationships. The GiA study design will use pre-determine genetic variants of interest to investigate the effect of genotype on phenotypic outcomes (genotype-biomarker-phenotype). Furthermore, the GiA study design will require a large and traceable pre-genotype population. Participant selection using pre-determined genetic variants improves statistical power by eliminating recruitment of non-informative participants, thus providing major ethical benefits.
The existing resource of the MRC-Gambia Keneba Biobank will be used as the basis for study participant selection. This resource allows individuals from rural Gambia to be recalled from an area, where a recent survey reported that anaemia affects 60% and 73% of child-bearing women and children respectively. Participants will be selected from a database comprising of data on >3000 Gambians, with Illumina HumanExome array data on 80K directly genotyped putative functional variants as well as imputation data on 20M variants.
- Conditions
- Anemia
- Medical subject headings
- Anemia
What is being measured
The primary outcome is the main question the study is designed to answer.
transferrin saturation (TSAT)
TSAT level as a proxy measure for iron absorption
Measured: at 5 hours
Secondary outcomes (3)
iron markers
these iron biomarkers (hepcidin, serum iron levels, serum ferritin, total iron binding capacity, serum transferrin, soluble transferrin receptor (sTfR)), will be measured
Measured: at baseline and at 5 hours after iron supplementation
haematology parameters
haematological parameters (haemoglobin, red blood cell indices measured from full blood count)
Measured: at baseline and at 5 hours after iron supplementation
inflammatory markers
inflammatory markers (C-reactive protein),
Measured: at baseline and at 5 hours after iron supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start5 Sep 2016
- Primary completion22 Mar 2019
- Study completion29 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford
- Responsible party
- Sponsor
- Investigators
- Carla Cerami, MD, PhD, Principal investigator, Medical Research Council The Gambia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03341338
- Sponsor's protocol ID
- SCC 1429
- Status last verified
- Aug 2019
- First submitted
- 20 Jul 2017
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jallow MW, Campino S, Saidykhan A, Prentice AM, Cerami C. Common Variants in the TMPRSS6 Gene Alter Hepcidin but not Plasma Iron in Response to Oral Iron in Healthy Gambian Adults: A Recall-by-Genotype Study. Curr Dev Nutr. 2021 Feb 24;5(3):nzab014. doi: 10.1093/cdn/nzab014. eCollection 2021 Mar.
PubMed 33817543
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
- Assessing the Effects of Genetic Variations Within the Hepcidin Pathway Genes on Oral Iron Absorption Using a Genes-in-Action Study Design
- ClinicalTrials.gov ID
- NCT03341338
- Acronym / sponsor ID
- SCC 1429
- Conditions
- Anemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- University of Oxford
- Study start
- 5 Sep 2016 (actual)
- Primary completion
- 22 Mar 2019 (actual)
- Study completion
- 29 Apr 2019 (actual)
- First posted
- 14 Nov 2017 (actual)
- 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.
Anaemia continues to be one of the most common health problems affecting children and pregnant women in low-income countries. Nutritional iron deficiency is believed to be the main driver of anaemia, so mass iron supplementation and food fortification programs have been recommended by most public health organizations. However, these interventions are frequently ineffective and new strategies are desperately needed.
Both anaemia and iron absorption are influenced by multiple factors, including nutritional status, infection, low grade inflammation and host genetics. The discovery of hepcidin, the master regulator of iron absorption and regulation has opened new avenues for investigation. Genome-wide association studies have identified several single nucleotide polymorphisms (SNPs) within hepcidin regulatory genes that are associated with altered iron status both in African populations.
The study aims to investigate the impact of genetic alterations in hepcidin regulation on oral iron absorption. A recall-by-genotype study will be conducted using an existing database of pre-genotype individuals in rural Gambia (West Kiang). This database comprise of data on >3000 Gambians, with Illumina HumanExome array data on 80K directly genotyped putative functional variants as well as imputation data on 20M variants.
Detailed description
Anaemia is a recalcitrant problem in global health, affecting particularly children and childbearing women in sub-Saharan Africa. Anaemia causes impaired growth and cognitive development in children, poor pregnancy outcomes including both maternal and perinatal mortality. Also, it is associated with poor economic growth due to its impact on physical activity.
Mass iron supplementation and food fortification are commonly used to combat anaemia in low- and middle-income countries. This due to the fact that the main driver of anaemia is thought to be nutritional iron deficiency. However, these programs have had little impact in sub-Saharan Africa and new strategies are desperately needed.
Low-cost oral iron tablets and micronutrient powders are routinely given to treat and prevent anaemia in both children and pregnant women. However, often these interventions are frequently ineffective, never very effective, and may even cause harm by increasing susceptibility to infections. Both the aetiology of anaemia and the efficacy of iron absorption are complex processes influenced by multiple factors, including nutritional status, infection and host genetics.
Hepcidin, a 25-amino acid liver-produced hormone is the master regulator of body iron status. Hepcidin controls plasma iron influx through its interaction with ferroportin - the only known cellular iron channel. Hepcidin's binding to ferroportin leads to the degradation and internalisation of the latter, thereby blocking iron traffic from macrophages, hepatocytes and duodenal enterocytes, into the plasma. Hepcidin secretion is dampened by hypoxia, erythroid drive and iron deficiency, to enable iron absorption, whereas, iron sufficiency/overload and infection enhances hepcidin transcription.
Hepcidin transcription is regulated by a number of signals and pathways. At the molecular level, the regulation of hepcidin expression is complex, but one of the key regulators is TMPRSS6 (transmembrane protease serine 6). TMPRSS6 (also called matriptase-2) is a type II transmembrane serine protease principally expressed in the liver. TMPRSS6 indirectly regulates hepcidin transcription, by interfering with the bone morphogenetic protein (BMP), hemojuvelin (HJV), and son of mothers against decapentaplegic homolog (SMAD) signalling pathway. TMPRSS6 decreases hepcidin transcription by cleaving hemojuvelin (HJV), thus, reducing BMP-SMAD signalling. Cleavage of membrane-bound HJV, the BMP receptor, by TMPRSS6 leads to BMP reduction, thereby decreasing BMP, resulting in hepcidin repression as BMP-HJV signalling is required for hepcidin transcription. TMPRSS6 is the main negative regulator of hepcidin expression and functional variants leas to iron-refractory iron deficiency anaemia (IRIDA).
Due to its central role in iron homeostasis, most inherited iron pathologies arise from genetic defects in genes encoding proteins that regulate hepcidin or in the hepcidin gene (HAMP) itself. Genetic variations that inactivate HAMP expression result in hepcidin deficiency, which has been implicated inherited iron-loading diseases such as hereditary hemochromatosis (HH). In contrast, genetic alteration that lead to elevated ristrictis iron availability. For instance, genetic defects that curtail the expression of TMPRSS6 results in elevated hepcidin, thereby causing anaemia that is resistant to oral iron supplementation, IRIDA.
This project aims to investigate the impact of functional single nucleotide polymorphisms (SNPs) in the genes within the hepcidin regulatory pathways that are known or proposed to predispose to low iron status. To begin with, the focus will be on three common SNPs within the TMPRSS6 gene, rs855791, rs4820268 and rs2235321, with minor allele frequencies (MAF) at 7, 27 and 44% in the study population. These SNPs were selected with reference to previous association and genome-wide association (GWA) studies. All three SNPs have been significantly associated with fall in plasma iron status biomarkers, including serum iron, haemoglobin concentrations, transferrin saturation, and a rise in hepcidin levels, as well as iron deficiency anaemia in both association and GWA studies.
The hypothesis is that risk alleles will cause a baseline increase in serum hepcidin levels and that individuals with these SNPs will absorb iron less effectively than those with the wild-type alleles. Subsequently, more functional or putative functional SNPs within the TMPRSS6 gene and other hepcidin/iron-related genes such as TF, SLC11A2, TFR2 will be investigated.
Several GWAS have to identified dozens of SNPs association associated with low iron status. Although these studies can detect phenotype-genotype associations, they fail to reveal functional and mechanism underlying genotype-phenotyoe relationships. For instance, this approach may be misleading due influence of variations in interim phenotypes, especially in relation to genetic predictors of infections. Thus, in order to overcome this limitation, the investigators will employ a recall-by-genotype paradigm the investigators termed 'Genes-in-Action' (GiA) to understand genotype-phenotype relationships and identify causal relationships. The GiA study design will use pre-determine genetic variants of interest to investigate the effect of genotype on phenotypic outcomes (genotype-biomarker-phenotype). Furthermore, the GiA study design will require a large and traceable pre-genotype population. Participant selection using pre-determined genetic variants improves statistical power by eliminating recruitment of non-informative participants, thus providing major ethical benefits.
The existing resource of the MRC-Gambia Keneba Biobank will be used as the basis for study participant selection. This resource allows individuals from rural Gambia to be recalled from an area, where a recent survey reported that anaemia affects 60% and 73% of child-bearing women and children respectively. Participants will be selected from a database comprising of data on >3000 Gambians, with Illumina HumanExome array data on 80K directly genotyped putative functional variants as well as imputation data on 20M variants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adult Gambians (aged >18 years) with available genotype data from a cohort of 3118 individuals
Key inclusion criteria (3 listed)
- Be healthy and over 18 years of age old.
- Have provided appropriate ethical consent for involvement in studies relating to genetics.
- Have available genotype data based on previous or ongoing genetic studies. Fasted (overnight)
Key exclusion criteria (4 listed)
- Indication of infection/inflammation at the time of enrollment as determined by self-reporting, medical history or hematology (full blood count)
- Severe anemia (HGB<7 g/dL)
- Pregnant and lactating women
- Carrier of known genetic variants associated with iron metabolism (sickle trait, G6PD deficiency variants, HFE polymorphisms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
transferrin saturation (TSAT)
Time frame: at 5 hours
TSAT level as a proxy measure for iron absorption
3 secondary outcomes
iron markers
Time frame: at baseline and at 5 hours after iron supplementation
haematology parameters
Time frame: at baseline and at 5 hours after iron supplementation
inflammatory markers
Time frame: at baseline and at 5 hours after iron supplementation
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 33817543Jallow MW, Campino S, Saidykhan A, Prentice AM, Cerami C. Common Variants in the TMPRSS6 Gene Alter Hepcidin but not Plasma Iron in Response to Oral Iron in Healthy Gambian Adults: A Recall-by-Genotype Study. Curr Dev Nutr. 2021 Feb 24;5(3):nzab014. doi: 10.1093/cdn/nzab014. eCollection 2021 Mar.
- Individual participant dataSharing planned: No
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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.
Carla Cerami, MD, PhD principal investigator
Medical Research Council The Gambia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia, 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 3 inclusion and 4 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
transferrin saturation (TSAT) (time frame: at 5 hours). 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 NCT03341338, which also lists 1 linked publication.
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.