GI Effects of Iron in Healthy Volunteers

Iron Deficiency Anemia Clinical Trial

Official title: Investigating the Effects of Iron on the Gastrointestinal Tract in Health.

Status Completed

Clinical Trial Summary

Over recent years there has been a lot of research looking at how the bacteria in our gut affects our health. Some medications are known to cause changes in gut bacteria.

Many patients that are prescribed iron report gastrointestinal side effects. This research project aims to see if the cause of the gastrointestinal side effects is due to iron causing changes in the gut bacteria. This can be detected via measuring the levels of hydrogen and methane and other compounds in the breath and stool.

Clinical Trial Description

Iron deficiency anaemia is the most common health issue worldwide, with approximately >1.2 billion people affected. In the UK, iron deficiency anaemia most commonly affects pre-school aged children and women aged 15-49 years. In 2011, an estimated 14% of non-pregnant, and 23% of pregnant women in the UK had iron deficiency anaemia, and 2-5% of male and post-menopausal women were also affected. Whilst compared to other areas of the world IDA has a mild public health significance to the UK, it can be the reason for up-to 13% of referrals to gastroenterologists.

Treating IDA with oral supplements or IV infusions are both effective at restoring bodily iron stores. However, success is often greater in those receiving their iron intravenously, due to frequent non-adherence to oral tablets as a result of their side effects. Gastrointestinal complaints, most commonly constipation, are reported by up to 60% of people that take oral iron supplements. These GI complaints causes up to 50% of patient to not follow their treatment plan, meaning their iron deficiency anaemia persists. However, patients that receive intravenous iron infusions instead do not report these symptoms. This suggests that oral iron has an impact on the GI tract as intravenous iron will bypass the gastrointestinal lumen but the mechanism of this remains uncertain.

To investigate the side effects of oral iron supplements and research a potential mechanism for the cause of iron supplement side effects, this study will require healthy volunteers to take ferrous sulphate for 4 weeks. Pre and post intervention participants will be required to provide a stool sample, complete a breath test and answer questionnaires. ;

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Communicable Diseases
• Deficiency Diseases
• Infections
• Iron Deficiency Anemia
• Iron Deficiency Anemia Treatment
• Iron-deficiency
• Microbial Colonization

• NCT number: NCT04705662
• Study type: Interventional
• Source: The Functional Gut Clinic
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Completion date: June 30, 2022