Iron Deficiency AnemiaNCT07657455
Daily Versus Alternate-Day Oral Iron Therapy for Anemia in Second-Trimester Pregnancy
A study testing Ferrous Sulfate in people with Iron Deficiency Anemia and Anemia in Pregnancy, run by Pakistan Air Force (PAF) Hospital Islamabad at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Iron Deficiency Anemia, Anemia in Pregnancy
- What is being tested?
- Ferrous Sulfate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 sitePakistan
- Study dates
- Sep 2026to Feb 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Daily Versus Alternate-Day Oral Iron Therapy for Anemia Correction in Second-Trimester Pregnant Patients: A Randomized Controlled 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.
Read the detailed description
Iron deficiency anemia is the leading cause of anemia in pregnancy. Although daily oral iron is standard first-line therapy, it is frequently associated with gastrointestinal side effects and poor adherence. Because hepcidin rises after an iron dose and remains elevated for 24 to 48 hours, daily dosing may reduce fractional absorption; alternate-day dosing allows hepcidin to fall between doses, potentially improving absorption and tolerance.
This single-center, prospective, randomized, parallel-group trial will recruit pregnant women (13 to 27 weeks gestation) with hemoglobin below 11 g/dL and serum ferritin below 30 ng/mL from the antenatal clinic at PAF Teaching Hospital, Islamabad. Eligible, consenting participants will be randomized 1:1 to daily ferrous sulfate (one 325 mg tablet, approximately 65 mg elemental iron, once daily) or alternate-day ferrous sulfate (two 325 mg tablets, approximately 130 mg elemental iron, every other day) for four weeks.
The primary outcome is change in hemoglobin from baseline to Week 4. Secondary outcomes are change in serum ferritin, treatment adherence (proportion taking at least 80 percent of doses, by pill count and diary), and the frequency and severity of gastrointestinal side effects. Outcome assessors (laboratory personnel) are blinded to allocation; participant blinding is not feasible given the differing dosing schedules. Planned enrollment is 184 participants (92 per group), giving 90 percent power to detect a 0.40 g/dL difference in hemoglobin change at a two-sided alpha of 0.05, assuming a standard deviation of 0.83 g/dL.
- Conditions
- Iron Deficiency Anemia, Anemia in Pregnancy
- Being tested
- Ferrous Sulfate
- Keywords
- oral iron, ferrous sulfate, alternate-day dosing, hepcidin, second trimester, adherence
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrous SulfateDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Daily Iron | Active comparator | One ferrous sulfate 325 mg tablet (approximately 65 mg elemental iron) once daily for four weeks. Receives: Drug: Ferrous Sulfate |
| Alternate-Day Iron | Experimental | Two ferrous sulfate 325 mg tablets (approximately 130 mg elemental iron) every other day for four weeks. Receives: Drug: Ferrous Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 4
Secondary outcomes (4)
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.
Measured: Baseline and Week 4
Treatment adherence
Proportion of participants taking at least 80 percent of prescribed doses, determined by pill count cross-checked against patient dose diaries.
Measured: Through Week 4
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.
Measured: Through Week 4
Severity of gastrointestinal side effects
Severity of reported gastrointestinal side effects graded as mild, moderate, or severe on a structured checklist.
Measured: Through Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pakistan Air Force (PAF) Hospital Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ammara Suleman, Pakistan Air Force (PAF) Hospital Islamabad
- Investigators
- Ammara Suleman, MBBS, Principal investigator, Pakistan Air Force (PAF) Hospital Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07657455
- Sponsor's protocol ID
- IRON-DvA-2026-01
- Status last verified
- Jun 2026
- First submitted
- 14 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided