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.: PACTR202209728463176 Date of Approval: 13/09/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of enteral protein supplements on malnourished hemodialysis patients
Official scientific title Effect of intradialytic oral nutritional supplementation on nutritional markers in chronic malnourished hemodialysis patients
Brief summary describing the background and objectives of the trial Malnutrition is prevalent in chronic hemodialysis (HD) patients. It is due to inflammation, decreased intake of nutrients, loss of amino acids during dialysis, catabolic effect of dialysis and acidosis. It increases mortality and affects negatively on quality of life. The aim of this study is to assess the effect of intradialytic oral nutritional supplement (ONS) on nutritional markers in chronic HD patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Kidney Disease
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/09/2022
Actual trial start date
Anticipated date of last follow up 15/12/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants)
Recruitment status 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
Experimental Group NEOMUNE Otsuka 100 gm per hemodialysis session 3 months The powder was given in a dose of 100 gm per session mixed and dissolved in 250 ml warm water by shake in closed container and then consumed over the HD session 35
Control Group dietary counselling 3 months Control group will receive only the dietary counselling to increase dietary protein intake and consume calorie-dense foods. 35 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
adults with age ≥ 18 years, receiving maintenance HD thrice weekly for at least 6 months, and had protein energy wasting (PEW) defined as serum albumin level ≤ 3.5 g/dL (8,9,10) and prealbumin < 20 mg/dl infections, cirrhosis, enteropathy, metastatic malignancy, current treatment with immunosuppressive agents or corticosteroid, history of allergy to any component of used ONS and inadequate dialysis (Kt/V < 1.2) Adult: 19 Year-44 Year 18 Year(s) 75 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 03/09/2022 Ahmed Maher Teaching Hospital
Ethics Committee Address
Street address City Postal code Country
341 Port Said St. El Sayeda Zeinab cairo 11617 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome change in serum albumin level after 3 months
Secondary Outcome change in serum prealbumin, TIBC, hs-CRP, ferritin, cholesterol and dry body weight after 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ahmed Maher Teaching Hospital 341 Port Said St. El Sayeda Zeinab Cairo 11617 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed Maher Teaching Hospital 341 Port Said St. El Sayeda Zeinab cairo 11617 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mariam Shaker Nazeh -Khalifa El-Maamoun, Mansheya El-Bakry, Heliopolis cairo 11774 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mariam Nazeh mnshaker90@gmail.com +201271124880 El-Khalifa El-Maamoun, Mansheya El-Bakry, Heliopolis
City Postal code Country Position/Affiliation
cairo 11774 Egypt Ahmed Maher Teaching Hospital
Role Name Email Phone Street address
Public Enquiries mohamed gharib mohamedsary@med.asu.edu.eg +201000322177 new city of Obour , Almagd district
City Postal code Country Position/Affiliation
Qalyubiyya province 11828 Egypt ain shams university faculty of medicine internal medicine department
Role Name Email Phone Street address
Scientific Enquiries mohamed gharib mohamedsary@med.asu.edu.eg +201000322177 new city of Obour , Almagd district
City Postal code Country Position/Affiliation
Qalyubiyya province 11828 Egypt ain shams university faculty of medicine internal medicine department
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes i would share the results of this study with in 6 months from study termination Statistical Analysis Plan,Study Protocol 6 months from study termination the access will be open
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