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.: PACTR201908553469676 Date of Registration: 05/08/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title LETICIA Protocol Trial
Official scientific title Combination Food-Based and Supplemental Iron Replacement Therapy for Children with Moderate-to-Severe Anaemia in a Rural Ghanaian Setting: A Proof-of-Concept Study
Brief summary describing the background and objectives of the trial Background and Significance According to the World Health Organization (WHO) iron deficiency is the most common nutritional deficiency worldwide and an important public health problem in low- and middle-income countries (LMICs). Causes of anaemia in LMICs like Ghana are usually multifactorial including malaria, hemolytic anaemias, and chronic blood loss from chronic parasitic infections including schistosomiasis and hookworm. Nutritional iron deficiency (ID) is the most common cause of iron deficiency anaemia (IDA). Factors accounting for inadequate supplies of dietary iron and micronutrients include poverty, a lack of nutritional supplementation, and food taboos. Anaemia may result when iron deficiency is severe, after the body’s iron stores are depleted and supply to the bone marrow is limited. Health care providers may transfuse patients to correct moderate-to-severe IDA rather than monitoring gradual correction of anaemia with dietary supplementation. This practice increases rates of blood transfusion with this procedure’s associated risks and economic costs to healthcare facilities. Correction of IDA using a combination of locally available food staples rich in iron along with well-monitored oral iron supplementation may reduce the need for blood transfusions. Main Objective The main objective of this proof of concept study is to determine whether children 6-59 months old hospitalized at the Agogo Presbyterian Hospital (APH) in the Asante-Akim North District of the Ashanti region of Ghana, who present with moderate-to-severe anaemia and given an oral iron supplementation plus an iron-rich food-based intervention – the intervention group – will demonstrate a greater final haemoglobin (Hb) concentration after two weeks compared to participants of similar characteristics in the control group who will receive oral iron supplementation in addition to their usual diet. Specific Objectives Hypothesis 1: We predict that hospitalized children with moderate-to-severe
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Haematological Disorders,Iron Deficiency Anaemia ,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/10/2019
Actual trial start date
Anticipated date of last follow up 31/08/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
Recruitment status Not yet 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 randomization using a randomization table created by a computer software program 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
Control Group Standard Arm 14 days Participants randomised to the control group will be allowed to continue their usual or typical home-based feeding practices in addition to the institution’s standard oral iron replacement therapy. Parents or guardians will be compensated financially for the meals during their children’s hospitalisation. The frequency and quality of meals provided will not be controlled. 50 Uncontrolled
Experimental Group Intervention Arm 14 days Participants in the intervention group will be provided with two iron-rich main meals from the pre-determined research menu per day and a snack. These meals will be prepared and served at the ward’s kitchen. Parents or LARs shall be allowed to join in the meal preparation and dishing to familiarise themselves with the ingredients and preparation. Participants will receive standard oral iron replacement therapy in addition as per the institutional practice. 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion Criteria include the following: Children 6 – 59 months; Hb between 40 and < 70g/L at the time of screening as measured by an automated haematology analyser; Haemodynamically compensated or stable, not urgently requiring RBC transfusion; Not critically ill and needing urgent intensive care and/or surgery; and No evidence of ongoing blood loss (overtly or per facility’s standards for occult blood loss diagnosis), haemolysis (normal urobilinogen levels on urine dipstick examination), infections and temperature spikes (blood culture positive and on antibiotics) Exclusion Criteria include the following: Acute phase of management for severe acute malnutrition, severe malaria and/or severe bacterial infection or sepsis requiring parenteral antibiotics; Haemodynamically unstable; heart failure, ongoing haemolysis or bleeding, on chemotherapy, aplastic anaemia; Surgery within 14 days of hospitalisation; Unable to take food or medications orally; and Recipient of chronic blood transfusion therapy Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 6 Month(s) 59 Month(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
No 26/07/2019 Kwame Nkrumah University of Science and Technology Committee for Human Research Publication and Ethics
Ethics Committee Address
Street address City Postal code Country
KNUST Kumasi 00233 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome for the study will be the Hb concentration at day 14 of treatment with either LETICIA protocol diet combined with standard oral iron replacement therapy in the intervention group and standard oral iron replacement with typical or usual diet in the control group. Red blood cell transfusion rates in both groups will also be measured to determine the failure rates in the two groups. Day 14 of treatment
Secondary Outcome Secondary outcome measures will include the measurements of RBC indices including MCV, MCH, RDW-CV and Ret-He and serum biochemical markers including SF, CRP, and sTfr levels for all participants We will determine the correlation between these RBC or haematological indices and the serum biochemical markers or iron status. Day 14 of treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Agogo Presbyterian Hospital Agogo High Street Asante Akim Agogo Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Fogarty International Center of the National Institutes of Health under grant number D43TW009345awarded to the Northern Pacific Global Health Fellows Program 31 Center Drive, MSC 2220 Bethesda 2220 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Lawrence Osei Tutu Bantama High Street Kumasi 1934 Ghana Individual
COLLABORATORS
Name Street address City Postal code Country
Prof Daniel Ansong School of Medical Science of Kwame Nkrumah University of Science and Technology Kumasi Ghana
Dr. Sarah Cusick PhD 717 Delaware St SE Minneapolis United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Lawrence Osei Tutu oseitutlaw@gmail.com +233208611834 Bantama High St
City Postal code Country Position/Affiliation
Kumasi Ghana Paediatrician
Role Name Email Phone Street address
Public Enquiries Lawrence Osei Tutu oseitutlaw@gmail.com +233208611834 Bantama High St
City Postal code Country Position/Affiliation
Kumasi Ghana KATH
Role Name Email Phone Street address
Scientific Enquiries Sarah Cusick scusick@umn.edu +16126252272 717 Delaware St SE
City Postal code Country Position/Affiliation
Minneapolis Ghana University of Minnesota
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 with investigators whose proposed use of the data has been approved by an independent review committee (“learned intermediary”) identified for this purpose. Study Protocol Beginning 9 months and ending 36 months following article publication. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata.
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