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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06285851
Other study ID # 23-0825
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 23, 2023
Est. completion date December 12, 2023

Study information

Verified date March 2024
Source University of Calgary
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date December 12, 2023
Est. primary completion date December 12, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria: - cis-gendered female 18-25years old - BMI <25 kg/m2 - engaging in moderate to vigorous physical activity for =3 hours per week Exclusion Criteria: - gastrointestinal issues (e.g. Irritable bowel disease/syndrome) - chronic illnesses - prescription medication (including oral contraceptives) - allergies to supplement ingredients - iron supplementation in the last 3 months

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
FeSC
Supplement

Locations

Country Name City State
Canada University of Calgary Calgary Alberta

Sponsors (2)

Lead Sponsor Collaborator
University of Calgary Lallemand Bio-Ingredients

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary GI Symptoms Gastrointestinal Symptoms Questionnaire (rating scale 1-7 where 1= the absence of symptoms and 7=severe symptoms) Daily for 14 days
Primary Gastrointestinal symptoms Patient-Reported Outcomes Measurement Information System (rating scale 0-4 where 0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much) Weekly for 14 days
Secondary Supplement Tolerability and Preferences Questionnaire Consumer preferences compared to standard of care (rating scale 0-4, where 0=not at all and 4=very much) 14 days
Secondary Recovery The Recovery-Stress Questionnaire (rating scale 0-6, where 0=never and 6= always) 14 days
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