NCT06665516

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 30, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

March 19, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2025

Completed
Last Updated

December 9, 2025

Status Verified

October 1, 2024

Enrollment Period

3 months

First QC Date

October 28, 2024

Last Update Submit

December 2, 2025

Conditions

Keywords

iron deficiencyfibromyalgiairon infusion therapychronic painpain managementdietsex and genderwomen's healthserotonin

Outcome Measures

Primary Outcomes (1)

  • 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.

    from enrollment to end of treatment after 3 months

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsCisgender women
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Female patients attending the DeGroote Pain Clinic

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DeGroote Pain Clinic

Hamilton, Ontario, L8S 4L8, Canada

Location

Related Publications (4)

  • 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.

  • GBD 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.

  • Pasricha 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.

  • Dugan 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.

Related Links

MeSH Terms

Conditions

Iron DeficienciesFibromyalgiaChronic PainAgnosiaCoitus

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesMuscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsSexual BehaviorBehavior

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2024

First Posted

October 30, 2024

Study Start

March 19, 2025

Primary Completion

June 9, 2025

Study Completion

June 9, 2025

Last Updated

December 9, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

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.

Locations