Clinical trial NCT04915196: Tolerability of Iron Therapy in Women With AUB
Official title: Investigation of Efficacy and Gastrointestinal Tolerability of Liposomally Bound Iron Compared to Ferrous Sulphate in Women With Abnormal Uterine Bleeding
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Iron Deficiency Anemia
Abnormal Uterine Bleeding
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2021-06-07
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Nongravid women age 18-50 yo that have been diagnosed with iron deficiency secondary to abnormal uterine bleeding

Brief summary: 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Subjective tolerability of oral administration
timeFrame: 8 weeks
Secondary outcomes:
measure: Hemoglobin
timeFrame: 8 weeks
measure: Hematocrit
timeFrame: 8 weeks
measure: Ferritin
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Calgary
name: Chandrew Rajakumar, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.