Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201804003188338 Date of Registration: 13/03/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Spatone Trial in Pregnant Nigerian Women
Official scientific title 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
Brief summary describing the background and objectives of the trial Spatone iron-Plus is an iron-rich naturally occurring mineral water from Trefriw wells in Gwynedd (Wales), which contains approximately 0.21mg of iron/ml as ferrous sulphate in solution. Spatone iron-Plus is usually packed in a sachet of 24ml containing 5mg Fe2+ at a PH of 2.9. Spatone iron-Plus provides iron in a highly bioavailable form. In pregnancy, the mean absorption from two sachets (10mg Fe2+) is between 28% and 34%. Although, studies have shown that Spatone iron-plus provides sufficient amount of elemental iron in pregnancy to meet the recommended daily requirements; these studies were conducted in developed countries where the prevalence of iron-deficiency and IDA are low. Therefore, the aim of this study is to assess the effect of Spatone iron plus on the haemoglobin concentration of pregnant women in Nigeria, a developing country with a high prevalence of IDA and iron deficiency. Study objectives To compare the effect of Spatone iron-plus solution versus ferrous sulphate tablets on the serum ferritin levels of pregnant women in Lagos University Teaching Hospital. To compare the rate of change of haemoglobin concentration in pregnant women in the two groups. To compare the rate of increase of serum ferritin concentration in pregnant women in the two groups. To assess the side-effect profile of Spatone iron-plus.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaemia in Pregnancy,Haematological Disorders,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 04/01/2018
Actual trial start date 04/01/2018
Anticipated date of last follow up 18/05/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Tablet ferrous sulphate [200mg tablet containing 60mg of elemental iron] One tablet of ferrous sulphate, once daily (60mg Fe2+ per 24-hour) 28 days Eligible participants will be randomized in equal proportion between sachet Spatone iron-plus solution and tablet ferrous sulphate. Each study participant will receive either the content of two sachets of Spatone, once daily (10mg per 24-hour) for 28 days, or one tablet of ferrous sulphate, once daily (60mg Fe2+ per 24-hour), for 28 days. 100 Active-Treatment of Control Group
Experimental Group Spatone iron-plus solution Two sachets [48ml] of Spatone iron-plus, once daily (dose of 10mg per 24-hour) 28 days Eligible participants will be randomized in equal proportion between sachet Spatone iron-plus solution and tablet ferrous sulphate. Each study participant will receive either the content of two sachets of Spatone, once daily (10mg per 24-hour) for 28 days, or one tablet of ferrous sulphate, once daily (60mg Fe2+ per 24-hour), for 28 days. 100
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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 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 18 Year(s) 44 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 19/06/2017 Lagos University Teaching Hospital, Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Ishaga Road Lagos 100254 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Haemoglobin concentration on day 28 post-randomization Day 0 (baseline) Day 28 post-randomization
Secondary Outcome Serum ferritin concentration on day 28 post-randomization Day 0 (baseline) Day 28 post-randomisation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Antenatal Outpatients' Clinic, Lagos University Teaching Hospital Ishaga Road Surulere, Lagos 100254 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Investigator-initiated Ishaga Road Surulere, Lagos 100254 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. George Obioma-Okorie Ishaga Road Surulere, Lagos 10025 Nigeria Funding Agency
Secondary Sponsor Dr, Christian Makwe Ishaga Road Surulere, Lagos 100254 Nigeria Funding Agency
Secondary Sponsor Dr. Vincent Osunkalu Ishaga Road Surulere, Lagos 100254 Nigeria Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Dr. George Obioma-Okorie Ishaga Road Surulere, Lagos 100254 Nigeria
Dr, Christian Makwe Ishaga Road Surulere, Lagos 100254 Nigeria
Dr. Vincent Osunkalu Ishaga Road Surulere, Lagos 100254 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Christian Makwe makwe285@yahoo.com +234-8033358021 Ishaga Road
City Postal code Country Position/Affiliation
Surulere, Lagos 100254 Nigeria University of Lagos/Lagos University Teaching Hospital
Role Name Email Phone Street address
Public Enquiries D, J, Akpan luthethics@yahoo.com +234-1-585737 Ishaga Road
City Postal code Country Position/Affiliation
Surulere, Lagos 100254 Nigeria Administrative Secretary
Role Name Email Phone Street address
Scientific Enquiries Njideka Okubadejo njide_okubadejo@yahoo.com +234-8023130243 Ishaga Road
City Postal code Country Position/Affiliation
Surulere, Lagos 100254 Nigeria University of Lagos/Lagos University Teaching Hospital
REPORTING
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