Alternate day versus daily oral iron therapy for treatment of iron deficiency anemia in children aged 2-15 years

A randomized controlled open-label clinical trial comparing alternate day versus daily oral ferrous sulfate therapy for improvement in hemoglobin levels in children aged 2-15 years with iron deficiency anemia at Lady Reading Hospital, Peshawar, Pakistan

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12626000880347

Enrollment

120

Registered

2026-07-17

Start date

2026-09-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Iron deficiency anemia (IDA) is a common health problem in children and is associated with impaired growth, cognitive development, and reduced immunity. Daily oral iron therapy is the standard treatment; however, it is often associated with gastrointestinal side effects, leading to poor compliance. This study is a randomized, controlled, open-label clinical trial conducted at Lady Reading Hospital, Peshawar, to compare the efficacy and tolerability of alternate-day versus daily oral iron therapy in children aged 2–15 years diagnosed with iron deficiency anemia. A total of 120 participants will be randomly allocated into two groups: one receiving daily iron supplementation and the other receiving alternate-day therapy for a duration of 12 weeks. The primary outcome is the change in hemoglobin levels after 12 weeks. Secondary outcomes include assessment of side effects, treatment compliance, and changes in iron indices such as serum ferritin and transferrin saturation. The study aims to determine whether alternate-day iron therapy is equally effective or superior to daily therapy, with fewer side effects and better adherence, thereby improving treatment outcomes in pediatric patients with iron deficiency anemia.

Interventions

Children will receive oral ferrous sulfate providing 3-6mg/kg/day of elemental iron on alternate days for a duration of 12 weeks. The medication will be administered orally and accompanied by vitamin C supplementation to enhance iron absorption Vitamin C dose will be oral 2-3mg/kg/day of vitamin C Adherence will be monitor by return of empty packs/blister strips.

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

2 Years to 15 Years

Healthy volunteers

Inclusion criteria

Children aged 2-15 years Diagnosed with Iron deficiency anemia Low hemoglobin with low serum ferritin Not receiving iron therapy or blood transfusion recently

Exclusion criteria

Severe anemia requiring urgent transfusion (Hemoglobin < 5 g/dl) Known hemoglobinopathies (thalassemia) Chronic kidney diseases affecting iron metabolism Allergy or intolerance to oral iron therapy

Outcome results