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.: PACTR201508001219405 Date of Approval: 26/07/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Role of Oral Iron in Patients with Heart Failure and Iron Deficiency in Tanzania
Official scientific title Role of Oral Iron in Patients with Heart Failure and Iron Deficiency in Tanzania: The Prospective Tanzania Heart Failure-Oral Iron Pilot Clinical Trial
Brief summary describing the background and objectives of the trial In patients with chronic heart failure (HF), iron deficiency is common and associated with increased morbidity and mortality, independent of anaemia. Intravenous (iv) iron does improve quality of life and may reduce HF hospitalization. However, iv iron is expensive and administration to large populations of HF patient there by infeasible, particularly in countries with limited health care resources. Oral Iron is an established therapy for treating iron deficiency but has not yet been widely tested in HF. Oral iron remains promising in resource limited settings because(1) It is easily available (2) easy to administer to patients (3) newer ferrous sulphate preparations may be better absorbed than older ferrous sucrose; (4) the pathophysiology or iron deficiency may differ geographically; and (5) oral iron is inexpensive.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) TaHeFII trial
Disease(s) or condition(s) being studied Circulatory System,Heart failure , iron deficiency,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 07/01/2015
Actual trial start date 07/01/2015
Anticipated date of last follow up 29/02/2016
Actual Last follow-up date 29/02/2016
Anticipated target sample size (number of participants) 102
Actual target sample size (number of participants) 102
Recruitment status Completed
Publication URL Not applicable
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
Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group None Not applicable Not applicable Not applicable 102
Experimental Group oral ferrous sulphate 200mg thrice a day three months Oral ferrous sulphate will be given to all eligible patients 102
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿Diagnosis of stable heart failure (both with reduced and preserved EF) based on Echo and NT-proBNP >300 ng/L ¿Iron deficiency defined as: serum ferritin level <100 ¿g/L or 100 - 299 ¿g/L with concurrent transferrin saturation <20%. ¿Age < 18 years ¿Pregnant and lactating women ¿Documented/known stage III-IV liver disease; ¿Documented/known stage III-IV HIV disease; ¿Documented/known malignancy ¿Evidence of active bleeding ¿Known allergic or intolerant to Iron tablets ¿Already receiving or indicated for iron supplements ¿Received blood transfusion in the last 4 weeks ¿Documented/known hemolytic anaemia ¿Documented/known folate/B12 deficiency ¿Severe anaemia (<8g/dl),Or Hb>15g/dl ¿Consent is not given 18 Year(s) 100 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 Muhimbili University Senate Research and Publication Commitee
Ethics Committee Address
Street address City Postal code Country
UN Road, Upanga Dar es Salaam 65001 United Republic of Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome increase in mean serum ferritin At baseline and at the end of three months
Secondary Outcome increase in mean left ventricular ejection fraction At baseline and at the end of three months
Secondary Outcome dencrease in mean NT-ProBNP levels At baseline and at the end of three months
Secondary Outcome increase in mean hemoglobin At baseline and at the end of three months
Secondary Outcome increase in mean 6-Minutes-Walk distance At baseline and at the end of three months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Muhimbili National Hospital UN Road, Upanga Dar es Salaam 65001 Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
Muhimbili University through SIDA-MUHAS capacity building Program UN Road, Upanga Dar es Salaam 65001 United Republic of Tanzania
Karolinska Institute Solna Stockholm 171 76 Sweden
German Academic Exchange Service (DAAD) Kennedyallee Bonn D-53175 Germany
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Muhimbili University through SIDA-MUHAS capacity building Program UN Road, Upanga Dar es Salaam 65001 Tanzania University
COLLABORATORS
Name Street address City Postal code Country
Peter Kisenge UN Road, Upanga Dar es Salaam 65000 United Republic of Tanzania
Julie Makani UN Road, Upanga Dar es Salaam 65001 United Republic of Tanzania
Johnson Lwakatare UN Road, Upanga Dar es Salaam 65000 United Republic of Tanzania
Lars Lund Solna Stockholm 171 76 Sweden
Camilla Hage Solna Stockholm 171 76 Sweden
lars Ryden Solna Stockholm 171 76 Sweden
Mohamed Janabi UN Road, Upanga Dar es Salaam 65000 United Republic of Tanzania
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abel Makubi makubi55@gmail.com 255713307170 UN Road, upanga
City Postal code Country Position/Affiliation
Dar es Salaam 65001 United Republic of Tanzania Muhimbili University of Health and Allied Sciences
Role Name Email Phone Street address
Public Enquiries Julie Makani makubi55@gmail.com 255754381551 UN Road, upanga
City Postal code Country Position/Affiliation
Dar es Salaam 65001 United Republic of Tanzania Muhimbili University of Health and Allied Sciences
Role Name Email Phone Street address
Scientific Enquiries Abel Makubi makubi55@gmail.com 255754381551 UN Road, upanga
City Postal code Country Position/Affiliation
Dar es Salaam 65001 United Republic of Tanzania Muhimbili University of Health and Allied Sciences
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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