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Clinical Trials/CTRI/2025/03/081855
CTRI/2025/03/081855
Not yet recruiting
Phase 3

Randomized controlled trial to evaluate the efficacy and safety of Oral Iron regimens differing in frequency among anaemic women of Coastal Karnataka.

K S Hegde Medical Academy1 site in 1 country90 target enrollmentStarted: April 14, 2025Last updated:
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Overview

Phase
Phase 3
Status
Not yet recruiting
Enrollment
90
Locations
1
Primary Endpoint
Change in heamoglobin levels from baseline and day 84.
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

We have obtained IEC approval for the study and are in the process of procuring materials and manpower required for the conduction of the study. The recruitment will begin from 10th March 2025 and the same will be updated on the CTRI website.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 49.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • •All women aged 18-49 years with haemoglobin levels less than 12 g/dl.

Exclusion Criteria

  • •regnant women, Hb less than 8 g/dl, Sickle cell anaemia, thalassaemia and other haemoglobinopathies.

Outcomes

Primary Outcomes

Change in heamoglobin levels from baseline and day 84.

Time Frame: At baseline and on day 84 after the start of intervention.

Secondary Outcomes

  • Change in serum ferritin levels, incidence of gastrointestinal symptoms, & compliance.(At baseline, 28 days, 56 days &and 84 days from start of intervention)

Investigators

Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Amit Kumar Rao

K S Hegde Medical Academy

Study Sites (1)

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