Frequency and Impact of Iron Deficiency in Pain Clinic Patients

December 2, 2025 updated by: McMaster University
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

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

81

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8S 4L8
        • DeGroote Pain Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Female patients attending the DeGroote Pain Clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
from enrollment to end of treatment after 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participation rate and frequency of positive responses to the questionnaire with the intent of assessing the feasability and value of a more extensive study.
Time Frame: a week after end of treatment.
Patients dealing with iron deficiency symptoms will provided treatment, whose efficacy will be measured through our self-report questionnaire given at the end of treatment. If positive, the data and research gathered will be used to run a larger trial.
a week after end of treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2025

Primary Completion (Actual)

June 9, 2025

Study Completion (Actual)

June 9, 2025

Study Registration Dates

First Submitted

October 28, 2024

First Submitted That Met QC Criteria

October 28, 2024

First Posted (Actual)

October 30, 2024

Study Record Updates

Last Update Posted (Estimated)

December 9, 2025

Last Update Submitted That Met QC Criteria

December 2, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRID

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD is not planned to be shared as this is a pilot study analysing the feasability of treatment. If successful, this can be scaled up nationwide at which point IPD will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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