Tolerability of Iron Therapy in Women With AUB

Study Overview
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Brief Summary
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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
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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. 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 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

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

Conditions
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Iron Deficiency Anemia, Abnormal Uterine Bleeding

Intervention / Treatment
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* Dietary Supplement: Liposomally-bound Iron


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ferrous Sulphate<br>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<br>* 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.<br>|
| Liposomally-bound Iron<br>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<br>* 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.<br>|

What is the study measuring?
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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 |