Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/CTRI/2023/08/056597
CTRI/2023/08/056597Not yet recruitingNot Applicable

Efficacy of alternate day versus daily oral iron therapy in children with iron deficiency anemia- A RANDOMIZED CONTROL TRIAL

DR PRANATI GROVER1 site in 1 country40 target enrollmentStarted: August 30, 2023Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
To assess the efficacy of alternate versus twice daily oral iron therapy in children with iron deficiency anemia
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Iron deficiency anemia is the leading cause of nutritional anemia in India.  It can cause both hematological as well as non hematological consequences such as stunted growth and impaired cognitive functions.Large amount of unabsorbed iron can cause gastric inflammation and decrease the compliance. Alternate day Iron therapy is more efficient than daily Iron therapy in improving the hemoglobin levels and this can be attributed to the increased hepcidin levels after daily Iron dose. Hepcidin is a negative regulator of iron absorption and increased levels will lead to decrease iron absorption.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Open Label

Eligibility Criteria

Ages
6.00 Month(s) to 10.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Patients between 6 months to 10 years of age diagnosed with iron deficiency anemia.

Exclusion Criteria

  • •Patients who have received blood transfusion in past 3 months, oral or injectable iron supplements, patients with hemoglobinopathies, premature infants born before 32 weeks of gestation, patient with active infection.

Outcomes

Primary Outcomes

To assess the efficacy of alternate versus twice daily oral iron therapy in children with iron deficiency anemia

Time Frame: Over a span of one year

Secondary Outcomes

  • 1. Effect of alternate versus twice daily oral iron therapy on serum hepcidin levels(2. To compare the GI side effects in both the groups that may affect the compliance.)

Investigators

Sponsor
DR PRANATI GROVER
Sponsor Class
Other [Principal Investigator]

Study Sites (1)

Loading locations...

Similar Trials

Completed
Phase 3
Daily vs. Every Other Day Oral Iron Supplementation in Patients With Absolute Iron Deficiency AnemiaAnemiaIron Deficiency Anemia
NCT03725384Sunnybrook Health Sciences Centre51
Completed
Not Applicable
Alternate Day vs. Daily Iron Supplementation in Iron Depleted WomenIron-deficiencyIron Deficiency Anemia
NCT05105438Swiss Federal Institute of Technology150
Completed
Not Applicable
Daily vs Alternate Day Iron Supplementation for Pregnant Women With Iron Deficiency AnemiaIron Deficiency Anemia
NCT03562143Icahn School of Medicine at Mount Sinai88
Completed
Phase 3
Iron Dextran Versus Oral Iron for Treating Iron Deficiency Anemia in Pregnant WomenAnemia
NCT03212781Assiut University66
Completed
Phase 4
Daily versus alternate day oral iron supplementation for the treatment of iron deficiency anaemia in pregnancy (IronMother)
2024-512064-61-00University College Dublin230