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OpenTrials
Completed

NCT Number: NCT06285851

A Novel Iron Supplement for Athletes: Phase I

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.

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Key information

Conditions

Constipation Bleeding Gastric Colic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cramp, Abdominal Diarrhea Infant, Newborn, Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Calgary

Calgary, Alberta, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FeSC

Dietary Supplement

Supplement

Primary outcomes

  1. GI Symptoms

    Time frame: Daily for 14 days

    Gastrointestinal Symptoms Questionnaire (rating scale 1-7 where 1= the absence of symptoms and 7=severe symptoms)

  2. Gastrointestinal symptoms

    Time frame: Weekly for 14 days

    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)

Secondary outcomes

  1. Supplement Tolerability and Preferences Questionnaire

    Time frame: 14 days

    Consumer preferences compared to standard of care (rating scale 0-4, where 0=not at all and 4=very much)

  2. Recovery

    Time frame: 14 days

    The Recovery-Stress Questionnaire (rating scale 0-6, where 0=never and 6= always)

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Lallemand Bio-Ingredients

Registry information

Official study title

Pilot Study for a Novel Iron-Based Supplement for Athletes

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 29, 2024
Registry last updated
Mar 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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