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.: PACTR202404598891273 Date of Registration: 26/04/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Role of Liquid Chlorophyll as Adjuvant Therapy in The Treatment of Iron Deficiency Anemia in Children
Official scientific title Role of Liquid Chlorophyll as Adjuvant Therapy in The Treatment of Iron Deficiency Anemia in Children
Brief summary describing the background and objectives of the trial Iron deficiency anemia (IDA) is a major health issue in children. It is one of the popular dietary deficiencies in underdeveloped nations. The etiology of children’s IDA are insufficient iron ingestion and increased demands by the different body organs as a result of quick growth . Iron deficiency has many side effects that affect the health of the children. Treatment of IDA depends upon the cause. The available treatment options can be given orally or via parenteral injection. Various oral iron forms are feasible, including ferrous or ferric salts. Chlorophyll has a porphyrin ring similar to that of heme in hemoglobin. Chlorophyll acts through variety of mechanisms which include: (i) antioxidant activity; (ii) modifier of genotoxic effect; (iii) inhibition of cytochrome P450 enzymes; (iv) induction of phase II enzymes; (v) increased level of gluta-thione S-transferase; (v) cell differentiation, cell arrest and apoptosis .The aim of this study is to evaluate role of liquid chlorophyll as adjuvant therapy in the treatment of iron deficiency anemia in children.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Haematological Disorders,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/05/2024
Actual trial start date
Anticipated date of last follow up 15/10/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
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 Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Iron polymaltose complex 6 mg/kg/day elemental iron 3 months Iron polymaltose complex oral syrup (50mg elemental iron 5ml) 30 Active-Treatment of Control Group
Experimental Group Iron polymaltose complex plus liquid chlorophyll Iron polymaltose complex 6 mg/kg/day elemental iron Liquid chlorophyll oral syrup will be given 5 ml once daily with a glass of water , the drug concentration is (100 mg/5ml) 3 months Iron polymaltose complex oral syrup 50 mg elemental iron/5 ml Liquid chlorophyll oral syrup (100 mg/5ml) 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children with iron deficiency anemia aged 1 -18 years. 1. Children with iron deficiency anemia who are not compliant with liquid chlorophyll therapy. 2. Children with iron deficiency anemia who are allergic to liquid chlorophyll. 3. Children with contraindication of oral iron therapy as: a. Acute infection. b. Gastric disease that may be exaggerated by oral iron therapy e.g gastritis , gastric ulcer. Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year,Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 1 Year(s) 18 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 20/01/2024 Faculty of Medicine Tanta University
Ethics Committee Address
Street address City Postal code Country
El Gharbia Governorate ,El Gash street Tanta 31511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome CBC parameters, serum iron profile and improvement of clinical manifestations of iron deficiency anemia. AT 1 month and 3 months after start of Liquid chlorophyll and its continuous administration for 3 months
Secondary Outcome Drug side effects AT 1 month and 3 months after start of Liquid chlorophyll and its continuous administration for 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospital Gharbia Governorate ,Al Gash street Tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
No funding source El Gharbia Governorate ,El Gash street Tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine Tanta University El Gharbia Govvernorate El Gash street Tanta 31511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Eman Mohammed Elaskary El-Gharbia Govenorate,. El-Gash st. Tanta 31527 Egypt
Dalia Mohamed Ayoub El-Gharbia Govenorate, El-Gash st. Tanta 31527 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Eman Elaskary eman_elaskary@yahoo.com +201003007638 El Gharbia governorate El Gash street
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Lecturer of Pediatrics
Role Name Email Phone Street address
Public Enquiries Dalia Ayoub dalia.ayoub@med.tanta.edu.eg 01066343989 El Gharbia governorate E-lGash street
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Lecturer of pediatrics
Role Name Email Phone Street address
Scientific Enquiries Dalia Ayoub dalia.ayoub@med.tanta.edu.eg +201066343989 Gharbia Governorate , El-Gash street
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Lecturer of Pediatrics
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We intend to share deidentified individual trial participant data. All of the individual participant data collected during the trial and after deidentification will be available for anyone who wishes to access the data for any purpose. Statistical Analysis Plan,Study Protocol after completion of research and publication of the paper on request
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