NCT03341338

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
206

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 5, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 14, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2019

Completed
Last Updated

August 14, 2019

Status Verified

August 1, 2019

Enrollment Period

2.5 years

First QC Date

July 20, 2017

Last Update Submit

August 13, 2019

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

  • transferrin saturation (TSAT)

    TSAT level as a proxy measure for iron absorption

    at 5 hours

Secondary Outcomes (3)

  • iron markers

    at baseline and at 5 hours after iron supplementation

  • haematology parameters

    at baseline and at 5 hours after iron supplementation

  • inflammatory markers

    at baseline and at 5 hours after iron supplementation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy adult Gambians (aged \>18 years) with available genotype data from a cohort of 3118 individuals

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Keneba Field Station

Fajara, The Gambia

Location

Related Publications (1)

  • 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.

    PMID: 33817543DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

DNA will be extracted from red cell pellet left overs from plasma for iron biomarkers are removed

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Carla Cerami, MD, PhD

    Medical Research Council The Gambia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2017

First Posted

November 14, 2017

Study Start

September 5, 2016

Primary Completion

March 22, 2019

Study Completion

April 29, 2019

Last Updated

August 14, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)