CTRI/2022/04/041763CompletedPhase 4
A single-arm, prospective study to evaluate the effects of oral nutritional supplementation in chronic kidney disease (CKD) patients on maintenance hemodialysis (MHD)
Dr Reddys Laboratories0 sites100 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Pms
Eligibility Criteria
Inclusion Criteria
- •1) Age ââ?°Â¥ 18 years
- •2) Subjects on maintenance hemodialysis diagnosed as malnourished (serum albumin concentration <4 g/dL and/or a loss of ââ?°Â¥ 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
Investigators
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