Spatone Trial in Pregnant Nigerian Women

A Randomized, 28-days, Parallel-group, Equivalence Study to Compare the Effectiveness of 10mg Fe2+ Spatone Iron-Plus and 60mg Fe2+ Ferrous sulphate in Improving Haemoglobin Status of Pregnant Women in Lagos University Teaching Hospital

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR201804003188338

Enrollment

200

Registered

2018-03-13

Start date

2018-01-04

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

Haematological Disorders Pregnancy and Childbirth Anaemia in Pregnancy

Interventions

Tablet ferrous sulphate [200mg tablet containing 60mg of elemental iron]

Spatone iron-plus solution

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Subjects willing and able to give informed consent for participation in the trial Pregnant women who have a singleton fetus Aged 18 to 44 years Gestational age between 14 and 27 weeks of pregnancy

Exclusion criteria

Exclusion criteria: Pregnant women with multifetal pregnancy History of allergy to iron containing preparation History of chronic medical conditions such as chronic renal failure, haemoglobinopathy History of chronic inflammatory/infectious diseases such as tuberculosis or HIV infection in pregnancy Inability to return for follow-up visit at 4 weeks after enrolment Severe anaemia or anaemia with clinical features of cardiac failure

Design outcomes

Primary

Measure	Time frame
Haemoglobin concentration on day 28 post-randomization	—

Secondary

Measure	Time frame
Serum ferritin concentration on day 28 post-randomization	—

Countries

Nigeria

Contacts

Public ContactD, J, Akpan

Administrative Secretary

luthethics@yahoo.com+234-1-585737

Outcome results

None listed

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