MedTrace Logo

A Clinical Study on Adherence and Efficacy of Different Doses of Active Iron in Treatment Resistant Subjects

NCT04778072 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-03-26

No results posted yet for this study

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 intolerance to oral iron. Subjects with intolerance and treatment failure due to oral iron (male and female subjects, aged 18 to 55 years, with mild to moderate iron deficiency, with or without anaemia) are eligible. Sixty subjects are randomised into three groups (14 mg elemental iron, 25mg elemental iron and 50mg elemental iron daily). The primary objective is to assess adherence/persistence (including using pill counts). Secondary objectives are to assess gastrointestinal tolerability, haematological efficacy and health related quality of life.

Conditions

Interventions

DIETARY_SUPPLEMENT

Ferrous sulfate 14mg once daily

ACTIVE IRON™ (ferrous sulfate) 14 mg elemental iron once daily with matching placebo

DIETARY_SUPPLEMENT

Ferrous sulfate 25mg once daily

ACTIVE IRON™ (ferrous sulfate) 25 mg elemental iron once daily with matching placebo

DIETARY_SUPPLEMENT

Ferrous sulfate 25mg twice daily

ACTIVE IRON™ (ferrous sulfate) 25 mg elemental iron twice daily

Sponsors & Collaborators

  • Solvotrin Innovations Ltd

    lead INDUSTRY

Principal Investigators

  • Shauni Fitzgerald, MSC · Atlantia Clinical Trials

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-08
Primary Completion
2021-04-09
Completion
2021-05-15

Countries

  • Ireland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04778072 on ClinicalTrials.gov