Tolerability of Iron Therapy in Women With AUB

Investigation of Efficacy and Gastrointestinal Tolerability of Liposomally Bound Iron Compared to Ferrous Sulphate in Women With Abnormal Uterine Bleeding

Telephone surveys of female patients using liposomally-bound iron and traditional iron sulphate preparations for the management of iron deficiency anemia to determine gastrointestinal tolerability.

Study Overview

• Status: Not yet recruiting
• Conditions: Iron Deficiency Anemia; Abnormal Uterine Bleeding
• Intervention / Treatment: Dietary supplement: Liposomally-bound Iron

Detailed Description

1. Rationale and Background:

   Abnormal uterine bleeding (AUB) affects women worldwide. In high income countries, heavy menstrual bleeding (a subset of AUB) is the most common cause of iron deficiency (ID) and iron deficiency anemia (IDA). Although estimates vary, it appears that 20-30% of IDA is a result of heavy menstrual bleeding. Oral iron replacement is a common treatment modality among patients diagnosed with IDA. However, traditional oral iron preparations commonly result in significant gastrointestinal side effects due to the metabolism of the complex that the iron is bound to. Gastrointestinal side effects related to iron therapy, including: metallic taste, nausea, flatulence, constipation, diarrhea, epigastric distress, vomiting, and melena. Therefore, liposomally bound iron is thought to provide a better side effect profile due to avoiding these traditional complexes. In theory, this will lead to higher rates of compliance and treatment efficacy if patients are not experiencing these side effects. Although we have limited data on the efficacy of this iron preparation, the literature suggests that other types of liposomally bound medications have similar efficacy as traditional preparations. Therefore, we believe that liposomally bound iron will provide an effective and well tolerated option for women suffering from IDA secondary to AUB.

2. Research Question and Objectives:

   How does a novel liposomally-bound iron therapy compare to ferrous sulphate in women with anemia secondary to abnormal uterine bleeding? 2a. Determine if it has less gastrointestinal side effects than ferrous sulphate 2b. Determine if it has similar efficacy to ferrous sulphate in correcting anemia secondary to abnormal uterine bleeding

3. Methods:

Pre-menopausal women, diagnosed with anemia secondary to abnormal uterine bleeding Recruitment via physician offices of gynecologists in Calgary, AB Two treatment arms, n=10 per arm Ferrous sulphate compared to treatment arm (liposomally bound iron) Baseline hemoglobin prior to iron therapy initiation Pre-op hemoglobin to compare efficacy of iron therapy Phone interview with patients using standardized, validated questionnaire to collect information regarding gastrointestinal side effects

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Chandrew Rajakumar, M.D.; Phone Number: 4039562017; Email: chandrew.rajakumar@uCalgary.ca
• Study Contact Backup: Name: Courtney Manuel, M.D.; Phone Number: 4039441437; Email: courtney.manuel@ahs.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Nongravid women age 18-50 yo that have been diagnosed with iron deficiency secondary to abnormal uterine bleeding

Description

Inclusion Criteria:

• Diagnosed with iron deficiency secondary to abnormal uterine bleeding

Exclusion Criteria:

• Postmenopausal, premenarchal and pregnant women are excluded, as they do not have regular uterine bleeding associated with menses.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ferrous Sulphate; Women age 18-50 yo that have been diagnosed with iron deficiency anemia secondary to abnormal uterine bleeding using Ferrous Sulphate for iron replacement	Dietary supplement: Liposomally-bound Iron; Ferric pyrophosphate microencapsulated in liposomal form is an over the counter natural health product approved by Health Canada and commonly used for iron replacement. If this product is prescribed as part of usual management of iron deficiency and patients consent to participation they will be contacted by telephone survey of gastrointestinal tolerability.
Liposomally-bound Iron; Women age 18-50 yo that have been diagnosed with iron deficiency anemia secondary to abnormal uterine bleeding using Liposomally-bound Iron for iron replacement	Dietary supplement: Liposomally-bound Iron; Ferric pyrophosphate microencapsulated in liposomal form is an over the counter natural health product approved by Health Canada and commonly used for iron replacement. If this product is prescribed as part of usual management of iron deficiency and patients consent to participation they will be contacted by telephone survey of gastrointestinal tolerability.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective tolerability of oral administration	Survey of gastrointestinal reactions to iron replacement	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin	Relative change of hemoglobin	8 weeks
Hematocrit	Relative change of hematocrit	8 weeks
Ferritin	Relative change of ferritin	8 weeks

Collaborators and Investigators

• Sponsor: University of Calgary
• Investigators: Principal Investigator: Chandrew Rajakumar, M.D., University Of Calgary

Publications and helpful links

General Publications

• Pereira DI, Couto Irving SS, Lomer MC, Powell JJ. A rapid, simple questionnaire to assess gastrointestinal symptoms after oral ferrous sulphate supplementation. BMC Gastroenterol. 2014 Jun 4;14:103. doi: 10.1186/1471-230X-14-103.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2021
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: May 31, 2021
• First Submitted That Met QC Criteria: May 31, 2021
• First Posted (Actual): June 7, 2021

Study Record Updates

• Last Update Posted (Actual): June 7, 2021
• Last Update Submitted That Met QC Criteria: May 31, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Uterine Diseases; Hematologic Diseases; Anemia, Hypochromic; Anemia; Iron Metabolism Disorders; Anemia, Iron-Deficiency; Hemorrhage; Uterine Hemorrhage
• Other Study ID Numbers: REB20-1546

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No