Status:
UNKNOWN
A Clinical Study on Adherence and Efficacy of Different Doses of Active Iron in Treatment Resistant Subjects
Lead Sponsor:
Solvotrin Innovations Ltd
Conditions:
Premenopause
Iron-deficiency
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
A randomized, placebo controlled, parallel group, double blind study to compare the 3-month adherence and efficacy of Active Iron in subjects with or at-risk of iron deficiency and a history of intole...
Detailed Description
More than 2.2. billion people worldwide have anaemia and half of this burden is caused by iron deficiency \[Lopez 2016\]. The commonest causes of iron deficiency are inadequate intake, poor absorption...
Eligibility Criteria
Inclusion
- Be able to give written informed consent
- Be between 18 and 55 years of age
- Have ferritin levels \<30 µg/L
- Have a history of intolerance to oral iron
- Have mild to moderate anaemia (haemoglobin ≥9.5 g/dL and \<12.0 g/dL for females and ≥10.0 g/dL and \<13.0 g/dL for males, up to 30 patients) or no anaemia (up to 30 patients)
- Be in generally good health as determined by the investigator
Exclusion
- A history of dairy allergy or are hypersensitive to any of the components of the test product,
- Are currently taking any iron supplements, or have done so in the previous 2 weeks,
- Current inflammatory bowel disease (Crohn's disease or ulcerative colitis),
- Severe anemia (females with hemoglobin \<9.5 g/dL and males with hemoglobin \<10.0 g/dL)
- Females that have started menopause,
- Females using extended-cycle birth control pills
- Have a significant acute or chronic, unstable and untreated disease or any condition, which contraindicates, in the investigator's judgement, entry to the study,
- Having a condition or have taken a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results; for example, no concurrent medication which interferes with the absorption of iron (e.g. tetracyclines, calcium supplements),
- Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial,
- Subjects may not be receiving treatment involving experimental drugs. If the subject has been in a recent experimental trial, these must have been completed not less than 30 days prior to this study,
- Have a malignant disease or any concomitant end-stage organ disease.
Key Trial Info
Start Date :
October 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 15 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04778072
Start Date
October 8 2018
End Date
May 15 2021
Last Update
March 26 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Atlantia Clinical Trials
Cork, Co Cork, Ireland, T23 R50R