Iron DeficiencyNCT06665516
Frequency and Impact of Iron Deficiency in Pain Clinic Patients
An observational study of Iron Deficiency and Fibromyalgia, run by McMaster University at 1 site in Canada.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Iron Deficiency, Fibromyalgia
- How many people
- 81 participants
- Where
- 1 siteCanada
- Study dates
- 19 Mar 2025to 9 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Study population: Female patients attending the DeGroote Pain Clinic
Who may be able to join
- 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.
Who cannot join
- The only exclusion criteria is unwillingness to participate
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Iron Deficiency, Fibromyalgia
- Keywords
- iron deficiency, fibromyalgia, iron infusion therapy, chronic pain, pain management, diet, sex and gender, women's health, serotonin
- Medical subject headings
- Iron Deficiencies, Fibromyalgia, Chronic Pain, Agnosia, Coitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients at risk of iron deficiency at the DeGroote Pain Clinic
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.
Measured: from enrollment to end of treatment after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start19 Mar 2025
- Primary completion9 Jun 2025
- Study completion9 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Iron DeficiencyStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06665516
- Sponsor's protocol ID
- BRID
- Status last verified
- Oct 2024
- First submitted
- 28 Oct 2024
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Murray CJL; GBD 2021 Collaborators. Findings from the Global Burden of Disease Study 2021. Lancet. 2024 May 18;403(10440):2259-2262. doi: 10.1016/S0140-6736(24)00769-4. No abstract available.
PubMed 38762327GBD 2021 Anaemia Collaborators. Prevalence, years lived with disability, and trends in anaemia burden by severity and cause, 1990-2021: findings from the Global Burden of Disease Study 2021. Lancet Haematol. 2023 Sep;10(9):e713-e734. doi: 10.1016/S2352-3026(23)00160-6. Epub 2023 Jul 31.
PubMed 37536353Pasricha SR, Tye-Din J, Muckenthaler MU, Swinkels DW. Iron deficiency. Lancet. 2021 Jan 16;397(10270):233-248. doi: 10.1016/S0140-6736(20)32594-0. Epub 2020 Dec 4.
PubMed 33285139Dugan C, MacLean B, Cabolis K, Abeysiri S, Khong A, Sajic M, Richards T; Women's Health research Collaborative. The misogyny of iron deficiency. Anaesthesia. 2021 Apr;76 Suppl 4:56-62. doi: 10.1111/anae.15432.
PubMed 33682094
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency and Impact of Iron Deficiency in Pain Clinic Patients
- ClinicalTrials.gov ID
- NCT06665516
- Acronym / sponsor ID
- BRID
- Conditions
- Iron Deficiency, Fibromyalgia
- Keywords
- iron deficiency, fibromyalgia, iron infusion therapy, chronic pain, pain management, diet, sex and gender, women's health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 19 Mar 2025 (actual)
- Primary completion
- 9 Jun 2025 (actual)
- Study completion
- 9 Jun 2025 (actual)
- First posted
- 30 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Female patients attending the DeGroote Pain Clinic
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- The only exclusion criteria is unwillingness to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Results publication: PubMed 38762327Murray CJL; GBD 2021 Collaborators. Findings from the Global Burden of Disease Study 2021. Lancet. 2024 May 18;403(10440):2259-2262. doi: 10.1016/S0140-6736(24)00769-4. No abstract available.
- Results publication: PubMed 37536353GBD 2021 Anaemia Collaborators. Prevalence, years lived with disability, and trends in anaemia burden by severity and cause, 1990-2021: findings from the Global Burden of Disease Study 2021. Lancet Haematol. 2023 Sep;10(9):e713-e734. doi: 10.1016/S2352-3026(23)00160-6. Epub 2023 Jul 31.
- Results publication: PubMed 33285139Pasricha SR, Tye-Din J, Muckenthaler MU, Swinkels DW. Iron deficiency. Lancet. 2021 Jan 16;397(10270):233-248. doi: 10.1016/S0140-6736(20)32594-0. Epub 2020 Dec 4.
- Results publication: PubMed 33682094Dugan C, MacLean B, Cabolis K, Abeysiri S, Khong A, Sajic M, Richards T; Women's Health research Collaborative. The misogyny of iron deficiency. Anaesthesia. 2021 Apr;76 Suppl 4:56-62. doi: 10.1111/anae.15432.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iron Deficiency and Fibromyalgia, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients at risk of iron deficiency at the DeGroote Pain Clinic (time frame: from enrollment to end of treatment after 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06665516, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.