An interventional study of FeSC in Constipation, Diarrhea and Cramp, Abdominal, sponsored by University of Calgary. Completed at 1 site in Canada. Open to female participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-28.
Sponsored by University of Calgary · Not applicable, Interventional, and Other
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.
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.
1,046 studies on the registry are indexed under Constipation; 161 are open to participants now.
This study's enrollment of 14 is below the median of 75 across 884 interventional studies indexed under Constipation.
Browse Constipation studies →University of Calgary is the lead sponsor of 703 studies on the registry; 196 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Iron-yeast complex
Dietary Supplement: FeSC
Supplement
GI Symptoms
Gastrointestinal Symptoms Questionnaire (rating scale 1-7 where 1= the absence of symptoms and 7=severe symptoms)
Time frame: Daily for 14 days
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)
Time frame: Weekly for 14 days
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)
Time frame: 14 days
Recovery
The Recovery-Stress Questionnaire (rating scale 0-6, where 0=never and 6= always)
Time frame: 14 days
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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