Genes-in-Action - Hepcidin Regulation of Iron Supplementation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03341338|
Recruitment Status : Completed
First Posted : November 14, 2017
Last Update Posted : August 14, 2019
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||206 participants|
|Official Title:||Assessing the Effects of Genetic Variations Within the Hepcidin Pathway Genes on Oral Iron Absorption Using a Genes-in-Action Study Design|
|Actual Study Start Date :||September 5, 2016|
|Actual Primary Completion Date :||March 22, 2019|
|Actual Study Completion Date :||April 29, 2019|
- transferrin saturation (TSAT) [ Time Frame: at 5 hours ]TSAT level as a proxy measure for iron absorption
- iron markers [ Time Frame: at baseline and at 5 hours after iron supplementation ]these iron biomarkers (hepcidin, serum iron levels, serum ferritin, total iron binding capacity, serum transferrin, soluble transferrin receptor (sTfR)), will be measured
- haematology parameters [ Time Frame: at baseline and at 5 hours after iron supplementation ]haematological parameters (haemoglobin, red blood cell indices measured from full blood count)
- inflammatory markers [ Time Frame: at baseline and at 5 hours after iron supplementation ]inflammatory markers (C-reactive protein),
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03341338
|Keneba Field Station|
|Principal Investigator:||Carla Cerami, MD, PhD||Medical Research Council The Gambia|