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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT03341338
Date of registration:	20/07/2017
Prospective Registration:	No
Primary sponsor:	London School of Hygiene and Tropical Medicine
Public title:	Genes-in-Action - Hepcidin Regulation of Iron Supplementation
Scientific title:	Assessing the Effects of Genetic Variations Within the Hepcidin Pathway Genes on Oral Iron Absorption Using a Genes-in-Action Study Design
Date of first enrolment:	September 5, 2016
Target sample size:	206
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT03341338
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Gambia

Contacts

Name:	Carla Cerami, MD, PhD
Address:
Telephone:
Email:
Affiliation:	Medical Research Council The Gambia

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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)

Exclusion Criteria:

- 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

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Anemia

Intervention(s)

Primary Outcome(s)

transferrin saturation (TSAT) [Time Frame: at 5 hours]

Secondary Outcome(s)

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]

Secondary ID(s)

SCC 1429

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Oxford

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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