Health Condition 1: N189- Chronic kidney disease, unspecified
Conditions
Interventions
Intervention1: CELEVIDA MAXX DLS (Oral Nutrition Supplement): For 1 serve mix 40g of powder with 180ml of water
Oral administration
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Dr Reddys Laboratories
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age � 18 years 2) Subjects on maintenance hemodialysis diagnosed as malnourished (serum albumin concentration 3)Body weight history of past 6 months 4)Subjects willing to participate in the study 5)Subjects willing to consume the nutritional drink as per the protocol
Exclusion criteria
Exclusion criteria: 1)Patients with recurrent acute illnesses 2)Body weight less than 40 kg 3)Documented history of dialysis noncompliance 4)Documented malabsorption syndromes 5)Chronic inflammatory diseases of unknown origin 6)Recent surgery within 3 months or during follow-up 7)Contraindications to any of the ingredients of the nutritional supplement 8)Major cardiovascular event, or death during follow-up; 9)Patients with nephrotic syndrome; 10)Patients with history of malignancy 11)Chronic liver disease 12)Pregnant and lactating women. 13)Patient taking any other nutritional supplement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of oral nutraceutical supplementation on the protein levels (change in serum albumin concentration) in patients with CKD on maintenance dialysis.Timepoint: Screening/Basline (Visit 1), Month 1 Follow up(Visit 2), Month 2 Follow up (Visit 3) Month 3 End of study (Visit 4) | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the nutritional status using 24-hour dietary recall, modified subjective global assessment from baseline to 3 months. 1. To assess the risk of malnutrition using hand grip strength from baseline to 3 months. 2. To assess the inflammation levels due to malnutrition using malnutrition inflammation score from baseline to 3 months. 3. To assess the rate of Protein-energy wasting (PEW) using anthropometric values; i.e., Body weight, Body Mass Index, Triceps skin fold thickness from baseline to 3 months. 4. To assess the rate of iron loss using hemoglobin levels from baseline to 3 months. 5. To assess the rate of recovery from malnutrition using serum pre-albumin levels from baseline to 3 months. 6. To assess whether the serum potassium and phosphorous levels are maintained from baseline to 3 months in patients with CKD on maintenance dialysis.Timepoint: Screening/Basline (Visit 1), Month 1 Follow up(Visit 2), Month 2 Follow up (Visit 3) Month 3 End of study (Visit 4) | — |
Countries
India
Contacts
Public ContactDr Rahul Rathod
Dr Reddys Laboratories Ltd
Outcome results
None listed