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 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202209576526787 Date of Approval: 26/09/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A comparative study of Hemoforce Family as a treatment for iron deficiency anaemia in Ghanaian patients.
Official scientific title A comparative study of the efficacy and safety of Hemoforce Family in the treatment of iron deficiency anaemia in a tertiary healthcare facility in Northern Ghana.
Brief summary describing the background and objectives of the trial Anaemia is a complex condition with many causes. One of the biggest contributors to anaemia is low intake of absorbable dietary iron to meet the needs of the body. Nutrient deficiencies, such as folic acid, vitamin B12, and zinc also directly or indirectly contribute to anaemia. Sodium feredetate (NaFeEDTA) is an iron chelate that has been used successfully as a dietary fortifier in several trials around the world, as in this form, the iron is protected from inhibitors of iron absorption. Despite of growing concern of iron deficiency anaemia (IDA), there is a scarcity of clinical data on usage pattern of newer iron form like sodium feredetate in anaemia patients from Ghana. Most of the clinical studies on iron salts have been conducted in western population. Keeping this in view, we have planned a clinical study that aims to assess the effect and safety of oral iron supplement (sodium feredetate plus multivitamins) versus other hematinic products containing different iron salts in native Ghana population.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) FERENA Study
Disease(s) or condition(s) being studied Anaemia,Haematological Disorders,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/12/2021
Actual trial start date 07/10/2022
Anticipated date of last follow up 28/02/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 200
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
TTHERC18082108 Tamale Teaching Hospital Ethical Review Committee
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 randomization using by using procedures such as coin-tossing or dice-rolling Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Hemoforce Family 8 weeks Sodium feredetate (NaFeEDTA) based hematinic syrup, also contains essential vitamins and minerals 50
Control Group Ferrous gluconate 8 weeks Ferrous gluconate based hematinic solution, also contains few other minerals 50 Active-Treatment of Control Group
Control Group Ferric ammonium citrate 8 weeks Ferric ammonium citrate based hematinic, also contains few essential vitamins 50 Active-Treatment of Control Group
Control Group Ferrous glycine sulphate 8 weeks Ferrous glycine suplhate based hematinic syrup 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Male or female (≥12 years) suffering from iron deficiency anaemia having hemoglobin between 9 to 12 g/dl. Patients or parents willing to provide written informed consent to use personal and/or health data prior to the entry into the study. Anaemia not linked to iron deficiency. Hemoglobin less than 9 g/dL. Allergy to iron derivatives. Any medical disorder like diabetes or tuberculosis (TB), viral hepatitis cirrhosis, renal disease, autoimmune disease. Those who had received parenteral iron treatment earlier within 3 months before the start of the study. Patients with history of chronic blood loss. Alcohol abuse within past 6 months. Hemosiderosis, hemochromatosis or other iron storage disorders. Patients with a history or present illness that is a malignant tumor or autoimmune disease. Patients who underwent oral administration of an iron preparation (including an over-the-counter drug or supplement) within 4 weeks before the screening. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 12 Year(s) 79 Year(s) Both
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 01/03/2022 Tamale Teaching Hospital Ethical Review Committee
Ethics Committee Address
Street address City Postal code Country
Tamale Teaching Hospital Tamale PO Box 16 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Hemoglobin measures at baseline, 3 weeks, and 8 weeks after treatment to determine efficacy Baseline, 3 weeks and 8 weeks
Secondary Outcome Ferritin levels Physician consultation and examination to determine General wellness (weight correction, weakness/lethargy) at baseline and 8 weeks Physician consultation and examination to determine side effects (constipation, nausea, organoleptic and others) Baseline and 8 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tamale Teaching Hospital Box 16, Tamale Teaching Hospital Tamale PO Box 16 Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Shalina Healthcare 30th floor, Almas Tower, JLT Dubai 340575 United Arab Emirates
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Shalina Healthcare 30th floor, Almas Tower, JLT Dubai 340575 United Arab Emirates Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kennedy Mensah Osei oseimensah72@gmail.com +233202260336 Tamale teaching hospital
City Postal code Country Position/Affiliation
Tamale PO Box 16 Ghana Head of Biomedical science department
Role Name Email Phone Street address
Public Enquiries Rahul Mandlik rahul.mandlik@shalina.com +97144309111 Shalina Healthcare, 30th floor, Almas Tower, JLT
City Postal code Country Position/Affiliation
Dubai 340575 United Arab Emirates Head medical affairs
Role Name Email Phone Street address
Scientific Enquiries Alhassan Mohammed Shamudeen shamudeenalh@gmail.com +233242266304 Tamale Teaching Hospital
City Postal code Country Position/Affiliation
Tamale PO Box 16 Ghana Head research and development department
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared through a publication in a scientific medical journal and or through a presentation in a health oriented conference and professional educational forums. Clinical Study Report The data will be shared through publication and it will be accessible immediately after publication with no end date. The data will be shared in a form of publication in a medical scientific journal, therefore it will be accessible to all healthcare professionals as well as common public
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information