Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201804003300204 Date of Registration: 06/04/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Camel Milk in Pediatric Diabetic Ketoacidosis.
Official scientific title Renoprotective Effect of Camel Milk in Pediatric Diabetic Ketoacidosis: A focus on TLR-4/MAPK axis.
Brief summary describing the background and objectives of the trial Camel milk (CM) known to be rich in bioactive components and an insulin-like protein, exhibits protective and alleviating anti-inflammatory, antioxidant, and hypoglycemic properties against diabetes, and diabetic nephropathy. It is plausible then that CM could possibly ameliorate the potentially life threatening consequences of diabetic ketoacidosis (DKA). We evaluated the use of CM as an adjunctive treatment to insulin on DKA-induced inflammation, in pediatrics, and further investigated its renoprotective activity and examined the possible involvement of the TLR-4/MAPK/NF-¿B signaling pathway.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine,Paediatrics,Pediatric diabetic ketoacidosis
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 02/09/2017
Actual trial start date 02/09/2017
Anticipated date of last follow up 01/03/2018
Actual Last follow-up date 15/02/2018
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 90
Recruitment status Completed
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 Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not 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 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 insulin adjusted daily dose three months protective effect of insulin monotherapy against complications of diabetic ketoacidosis in pediatrics 30
Experimental Group insulin + camel milk adjusted daily dose + 500 ml per day three months complementary treatment to insulin in protecting against diabetic ketoacidosis complications in pediatrics 30
Control Group Healthy control NA three months NA 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Newly diagnosed children with T1DM and DKA. The criteria for the diagnosis of T1DM who developed DKA are hyperglycaemia with blood glucose levels exceeding 11 mmol/L, heavy glycosuria (>55 mmol/L), ketonuria and metabolic acidosis (pH<7.30) with a bicarbonate level of <15 mmol/L and the presence of >5% dehydration Hypoglycemia, cardiovascular events, active cancers, pancreatitis, renal or acute infections 4 Year(s) 15 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 10/08/2017 Institutional Ethics Committee of the faculty of Medicine, Cairo University
Ethics Committee Address
Street address City Postal code Country
Faculty of Medicine, El Manial Cairo 11562 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Inflammatory mediators (IL-1B, IL-6, IL-18) all were measured by the end of the trial.
Primary Outcome TLR-4, MAPK and NF-kB messenger RNA levels all were measured 1 week after the last subject has finished his/her three months treatment period.
Primary Outcome TLR-4 expression level, KIM-1 and Lipocalin 2 all were measured 10 days after last subject has finished his treatment period
Primary Outcome SOD measured 2 days after the last subject has completed his/her treatment period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Diabetic Endocrine Metabolic Pediatric Unit, Abo El-Reesh Children Hospital, Cairo University Kasr Al Aini Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funded by the researchers
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine, Cairo University Kasr Al Aini Cairo Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Waleed A. Mohammed Faculty of Medicine, Kasr Al Aini Cairo 11562 Egypt
Hekmat M. El Magdoub Km 28 Cairo-Ismailia Road Cairo 00001 Egypt
Mona F. Schaalan Km 28 Cairo-Ismailia Road Cairo 00001 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hekmat El Magdoub hekmat.elmagdoub@gmail.com 00201021048054 Km 28 Cairo-Ismailia Road
City Postal code Country Position/Affiliation
Cairo 00001 Egypt Assistant Professor, Faculty of Pharmacy, Misr International University
Role Name Email Phone Street address
Public Enquiries Waleed Mohammed waleedalilab@yahoo.com 00201158034894 Faculty of Medicine, Kasr Al Aini
City Postal code Country Position/Affiliation
Cairo 11562 Egypt Associate Professor of Clinical Chemistry, Cairo University Hospital
Role Name Email Phone Street address
Scientific Enquiries Mona Schaalan mona.schaalan@miuegypt.edu.eg 00201002011100 Km 28 Cairo-Ismailia Road
City Postal code Country Position/Affiliation
Cairo 00001 Egypt Associate Professor, Faculty of Pharmacy, Misr International University
REPORTING
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