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Comparison of the efficacy and safety of carbonyl iron and ferrous sulphate for iron deficiency anaemia in pregnancy: A Randomized controlled clinical trial.

Comparison of the efficacy and safety of carbonyl iron and ferrous sulphate for iron deficiency anaemia in pregnancy: A Randomized controlled clinical trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202407830762218
Enrollment
180
Registered
2024-07-01
Start date
2024-07-01
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Pregnancy and Childbirth

Interventions

Carbonyl iron
ferrous sulphate

Sponsors

Hamzat Abdullahi
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: i-Pregnant Women aged 15 – 49 years between 13 to 28weeks’ gestation ii- Pregnant women with Hb <10g/dl or Pack cell volume <30% iii-Willing and able to give consent to participate in the study

Exclusion criteria

Exclusion criteria: 1. Medically confirmed significant bleeding, major surgery, or blood transfusion within the last 3 months 2. Severe symptomatic anaemia requiring blood transfusion 3. Anaemia confirmed to be from other known causes besides IDA, e.g. sickle cell anaemia 4. Clinically confirmed malabsorption syndrome 5. Hypersensitivity or known allergy to any forms of iron or known severe drug allergies 6. Severe allergic reactions such as severe asthma 7. History of autoimmune disease, e.g. systemic lupus erythematosus, rheumatoid arthritis 8. Patients with severe, acute or chronic, hepatic or renal failure, severe cardiac insufficiency. 9. Patients with complications like bleeding piles, excessive emesis, active peptic ulcer disease, diabetes mellitus, hypertension, eclampsia, hypothyroidism, hyperthyroidism, and evidence of any malabsorption diseases 10. Patients with acute febrile illness such as malaria 11. Patients with multiple gestation 12. Patients who has been on haematinics prior to antenatal booking

Design outcomes

Primary

MeasureTime frame
a. Increase in haemoglobin level (Hb) from enrolment baseline to 12 weeks after commencement of therapy. b. Change in RBC indices such as MCV,MCH,MCHC. c .Preterm birth

Secondary

MeasureTime frame
a.Efficacy and Safety of the study medication b.Need for blood transfusion c.Occurrence of adverse drug reactions such as vomiting, diarrhoea, epigastric pain, constipation, metallic taste, and dizziness d. Infant outcomes: birthweight, Apgar score, neonatal mortality.

Countries

Nigeria

Contacts

Public ContactMuftau Popoola

consultant

mufruq4u@yahoo.com+2348036351812

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026