Tolerability of Iron Therapy in Women With AUB

Iron Deficiency Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04915196
• Other study ID #: REB20-1546
• Status: Not yet recruiting
• Start date: July 1, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: May 2021
• Source: University of Calgary
• Contact: Chandrew Rajakumar, M.D.
• Phone: 4039562017
• Email: chandrew.rajakumar[@]uCalgary.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abnormal Uterine Bleeding
• Anemia, Iron-Deficiency
• Hemorrhage
• Iron Deficiency Anemia
• Uterine Hemorrhage

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective tolerability of oral administration	Survey of gastrointestinal reactions to iron replacement	8 weeks
Secondary	Hemoglobin	Relative change of hemoglobin	8 weeks
Secondary	Hematocrit	Relative change of hematocrit	8 weeks
Secondary	Ferritin	Relative change of ferritin	8 weeks