NCT06285851

A Novel Iron Supplement for Athletes: Phase I

Pilot Study for a Novel Iron-Based Supplement for Athletes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: University of Calgary · Academic / Other
• Sex: Female
• Age: 18 Years – 25 Years
• Healthy volunteers: Accepted

Summary

Female endurance athletes are susceptible to iron deficiency and this can impact their exercise performance. This study is a pilot trial to assess the tolerability of a novel iron supplement prior to conducting a clinical trial on the efficacy of the developed novel iron supplement on iron status and performance.

Detailed description

Current iron supplements on the market are commonly associated with side effects including gastrointestinal distress, nausea, vomiting, and constipation. As a solution, the investigators have developed a novel delivery system for iron supplementation that overcomes many of these limitations. The goal of this study is to assess the tolerability of the developed supplement and any associated symptoms before conducting a clinical trial on this product. Participants will consume 40mg of elemental iron every second day for 14 days. Participants will complete a daily survey in which they will report feelings of stress and recovery as well as gastrointestinal symptoms. Additionally, participants will complete a more thorough survey of gastrointestinal symptoms at baseline, the mid-point, and the end of the study.

Conditions

• Constipation
• Diarrhea
• Cramp, Abdominal
• Bleeding Gastric

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	FeSC	Supplement

Timeline

• Start date: 2023-11-23
• Primary completion: 2023-12-12
• Completion: 2023-12-12
• First posted: 2024-02-29
• Last updated: 2024-03-28

Locations

1 site across 1 country: Canada