Nutritional Supplement Study in Chronic Kidney Disease Patients who are on dialysis.
Not Applicable
Completed
- Conditions
- Chronic kidney disease, unspecified,
- Registration Number
- CTRI/2022/04/041763
- Lead Sponsor
- Dr Reddys Laboratories
- Brief Summary
This study is an single-arm, Single center, prospective study to evaluate the effect of oral nutraceutical supplementation on the protein levels when given twice daily for 3 months in 78 patients (≥ 18 years) with Chronic kidney disease (CKD) on maintenance hemodialysis (MHD) that will be conducted in India. The primary endpoint will be change in serum albumin concentration and the secondary endpoint will be change in 24-hour dietary recall in patients over the study period (3 months) in patients with CKD on maintenance dialysis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 78
Inclusion Criteria
- 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
- Primary Outcome Measures
Name Time Method To evaluate the effect of oral nutraceutical supplementation on the protein levels (change in serum albumin concentration) in patients with CKD on maintenance dialysis. Screening/Basline (Visit 1), Month 1 Follow up(Visit 2), Month 2 Follow up (Visit 3) Month 3 End of study (Visit 4)
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
BAN Hospital
🇮🇳Mumbai, MAHARASHTRA, India
BAN Hospital🇮🇳Mumbai, MAHARASHTRA, IndiaDr Arun ShahPrincipal investigator9821133935drarunshah56@gmail.com