Health TrialsbyHealthPanel

Daily Versus Alternate-Day Oral Iron Therapy for Anemia in Second-Trimester Pregnancy

ConditionsIron Deficiency AnemiaAnemia in Pregnancy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorPakistan Air Force (PAF) Hospital Islamabad

About this trial

This randomized controlled trial compares daily versus alternate-day oral iron supplementation in pregnant women with iron deficiency anemia during the second trimester. The study evaluates changes in hemoglobin and serum ferritin, treatment adherence, and gastrointestinal side effects to inform more patient-centered, physiologically aligned dosing strategies.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 to 40 years

Pregnant women in the second trimester (13 to 27 weeks gestation)

Hemoglobin below 11 g/dL with serum ferritin below 30 ng/mL

Singleton pregnancy

Disqualifiers

Known congenital or acquired hemoglobin disorders (e.g., thalassemia, hemoglobinopathies)

Chronic diseases affecting hemoglobin levels (e.g., chronic kidney disease, inflammatory disorders)

Bleeding disorders or a history of frequent blood loss

Gastrointestinal conditions impairing nutrient absorption (e.g., celiac disease or other malabsorption syndromes)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ferrous Sulfate

    Drug

    Oral ferrous sulfate 325 mg tablets (approximately 65 mg elemental iron per tablet) administered for four weeks according to the assigned dosing schedule. All participants receive standardized counseling on administration, diet, side effects, and adherence, and are issued a dose diary.

Treatment groups

184 Participants
are divided into 2 treatment groups
Group A: Daily IronActive comparator 1 intervention
Group B: Alternate-Day IronExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in hemoglobin from baseline to Week 4

Mean within-participant change in hemoglobin concentration (g/dL), measured at baseline and at Week 4, compared between the daily and alternate-day arms.

Time frame
Baseline and Week 4

Secondary outcomes

1

Change in serum ferritin from baseline to Week 4

Mean within-participant change in serum ferritin concentration (ng/mL) from baseline to Week 4, compared between groups.

Time frame
Baseline and Week 4
2

Treatment adherence

Proportion of participants taking at least 80 percent of prescribed doses, determined by pill count cross-checked against patient dose diaries.

Time frame
Through Week 4
3

Frequency of gastrointestinal side effects

Proportion of participants reporting any gastrointestinal side effect (nausea, vomiting, constipation, metallic taste, or abdominal discomfort) recorded using a structured checklist.

Time frame
Through Week 4
4

Severity of gastrointestinal side effects

Severity of reported gastrointestinal side effects graded as mild, moderate, or severe on a structured checklist.

Time frame
Through Week 4

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pakistan Air Force (PAF) Hospital Islamabad

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: