utritional Supplement Study in Chronic Kidney Disease Patients who are on dialysis.

Phase 4

Completed

• Conditions: Health Condition 1: N189- Chronic kidney disease, unspecified

• Registration Number: CTRI/2022/04/041763
• Lead Sponsor: Dr Reddys Laboratories

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-06-22
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

1) Age � 18 years

2) Subjects on maintenance hemodialysis diagnosed as malnourished (serum albumin concentration <4 g/dL and/or a loss of � 5% dry weight [DW] over the past 3 months)

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

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

Study & Design

• Study Type: PMS
• Study Design: Not specified