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

NCT07657455 | Not Yet Recruiting

• 1 other identifier: IRON-DvA-2026-01
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Iron Deficiency Anemia; Anemia in Pregnancy

Keywords

oral iron; ferrous sulfate; alternate-day dosing; hepcidin; second trimester; adherence

Outcome Measures

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.

  Baseline and Week 4

Secondary Outcomes (4)

• Change in serum ferritin from baseline to Week 4

  Baseline and Week 4

• Treatment adherence

  Through Week 4

• Frequency of gastrointestinal side effects

  Through Week 4

• Severity of gastrointestinal side effects

  Through Week 4

Study Arms (2)

Daily Iron

ACTIVE COMPARATOR

One ferrous sulfate 325 mg tablet (approximately 65 mg elemental iron) once daily for four weeks.

Drug: Ferrous Sulfate

Alternate-Day Iron

EXPERIMENTAL

Two ferrous sulfate 325 mg tablets (approximately 130 mg elemental iron) every other day for four weeks.

Drug: Ferrous Sulfate

Interventions

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.

Alternate-Day Iron; Daily Iron

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Currently receiving parenteral iron
• Requiring blood transfusion

Sponsors & Collaborators

• Pakistan Air Force (PAF) Hospital Islamabad: lead

Study Sites (1)

Pakistan Air Force (PAF) Hospital Islamabad

Islamabad, Pakistan

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

ferrous sulfate

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ammara Suleman, MBBS

  Pakistan Air Force (PAF) Hospital Islamabad

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ammara Suleman

CONTACT

+92 321 5279502; shazibnawaz2016@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participant and care-provider blinding is not feasible because the two arms follow visibly different dosing schedules. Outcome assessment is blinded: laboratory personnel analyzing hemoglobin and ferritin are masked to group allocation, with samples labeled by unique participant ID only.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 14, 2026
• First Posted: June 18, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: June 18, 2026

Record last verified: 2026-06

Locations

PA (1)