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OpenTrials
Completed

NCT Number: NCT06665516

Frequency and Impact of Iron Deficiency in Pain Clinic Patients

The goal of this study is to measure the proportion of patients who have iron deficiency and if iron deficiency is treated what is the outcome. Participants will fill out a questionnaire to assess positive impact of iron supplementation treatment to assess whether they are at potential risk of iron deficiency

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Key information

About this study

The study is an observational clinical audit, with an unblinded clinical intervention. Iron deficiency and some chronic pain syndromes like fibromyalgia are more common in women of reproductive age. Iron deficiency can present with symptoms that are similar to those of fibromyalgia, but once recognized, iron deficiency is typically easily treated. The investigators intend to poll patients at the DeGroote Pain Clinic based on information from studies conducted in Australia and Great Britain. The investigators will determine who is at risk for iron deficiency based upon symptoms such as heavy periods, history of pregnancy, blood donation, diet, and any previous iron deficiency. The investigators will then confirm the results with lab testing, and provide treatment if necessary. The goal is to find out the percentage of women with chronic pain who also have iron deficiency, and assess the effect of treating iron deficiency on their pain symptoms.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient at the DeGroote Pain Clinic
  • Menstruating women between the ages of 18-49
  • Willingness to complete the questionnaire, and undergo laboratory tests if indicated.

Exclusion criteria

  • The only exclusion criteria is unwillingness to participate

Treatment and study plan

Primary outcomes

  1. Proportion of patients at risk of iron deficiency at the DeGroote Pain Clinic

    Time frame: from enrollment to end of treatment after 3 months

    Our primary outcome is the proportion of the 81 patients who are at risk of iron deficiency. This will be measured through positive questionnaire responses with symptoms/conditions that indicate risk of iron deficiency. Women patients arriving for pain clinic visits will be asked if they wish to participate in this audit and complete a screening questionnaire.The questionnaire determines high risk for Iron Deficiency through known risk factors: heavy menstrual bleeding, previous iron status, and iron supplementation. Previous studies identified heavy menstrual bleeding as a significant predictor of anemia and progression into ID.7 Patients were asked to report any of the four major symptoms (need double sanitary protection, need to frequently change your protection, had or worried about flooding through to clothes or bedding, pass large blood clots.), with a yes to 2 or more being considered to describe heavy menstrual bleeding and therefore high risk for experiencing iron deficiency.

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 30, 2024
Registry last updated
Dec 9, 2025

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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