Iron Deficiency AnemiaNCT04915196
Tolerability of Iron Therapy in Women With AUB
An observational study of Iron Deficiency Anemia and Abnormal Uterine Bleeding, run by University of Calgary.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Iron Deficiency Anemia, Abnormal Uterine Bleeding
- What is being tested?
- Liposomally-bound Iron
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2021to 1 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Adult
Study population: Nongravid women age 18-50 yo that have been diagnosed with iron deficiency secondary to abnormal uterine bleeding
Who may be able to join
- Diagnosed with iron deficiency secondary to abnormal uterine bleeding
Who cannot join
- Postmenopausal, premenarchal and pregnant women are excluded, as they do not have regular uterine bleeding associated with menses.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the detailed description
- 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
- Conditions
- Iron Deficiency Anemia, Abnormal Uterine Bleeding
- Being tested
- Liposomally-bound Iron
- Medical subject headings
- Anemia, Iron-Deficiency, Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomally-bound IronDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Liposomally-bound Iron | |
| 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 Receives: Dietary Supplement: Liposomally-bound Iron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective tolerability of oral administration
Survey of gastrointestinal reactions to iron replacement
Measured: 8 weeks
Secondary outcomes (3)
Hemoglobin
Relative change of hemoglobin
Measured: 8 weeks
Hematocrit
Relative change of hematocrit
Measured: 8 weeks
Ferritin
Relative change of ferritin
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start1 Jul 2021 (estimated)
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chandrew Rajakumar, M.D., Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04915196
- Sponsor's protocol ID
- REB20-1546
- Status last verified
- May 2021
- First submitted
- 31 May 2021
- Last updated
- 7 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD
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.
PubMed 24899360
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Efficacy and Gastrointestinal Tolerability of Liposomally Bound Iron Compared to Ferrous Sulphate in Women With Abnormal Uterine Bleeding
- ClinicalTrials.gov ID
- NCT04915196
- Acronym / sponsor ID
- REB20-1546
- Conditions
- Iron Deficiency Anemia, Abnormal Uterine Bleeding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 7 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferrous Sulphate | – | Dietary Supplement: Liposomally-bound IronWomen age 18-50 yo that have been diagnosed with iron deficiency anemia secondary to abnormal uterine bleeding using Ferrous Sulphate for iron replacement |
| Liposomally-bound Iron | – | Dietary Supplement: Liposomally-bound IronWomen age 18-50 yo that have been diagnosed with iron deficiency anemia secondary to abnormal uterine bleeding using Liposomally-bound Iron for iron replacement |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Nongravid women age 18-50 yo that have been diagnosed with iron deficiency secondary to abnormal uterine bleeding
Key inclusion criteria (1 listed)
- Diagnosed with iron deficiency secondary to abnormal uterine bleeding
Key exclusion criteria (1 listed)
- Postmenopausal, premenarchal and pregnant women are excluded, as they do not have regular uterine bleeding associated with menses.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liposomally-bound IronFerric 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. | Dietary supplement | Ferrous Sulphate, Liposomally-bound Iron |
Primary outcome
Subjective tolerability of oral administration
Time frame: 8 weeks
Survey of gastrointestinal reactions to iron replacement
3 secondary outcomes
Hemoglobin
Time frame: 8 weeks
Hematocrit
Time frame: 8 weeks
Ferritin
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2021.
- Background: PubMed 24899360Pereira 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.
- Individual participant dataSharing planned: No. There is no plan to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chandrew Rajakumar, M.D. principal investigator
University of Calgary
Questions about this trial
What is this clinical trial studying?
An observational study of Iron Deficiency Anemia and Abnormal Uterine Bleeding, run by University of Calgary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chandrew Rajakumar, M.D. (4039562017, chandrew.rajakumar@uCalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective tolerability of oral administration (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04915196, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2021.