The Effect of a Renal Specific Oral Nutritional Supplement on Nutritional Status

Chronic Kidney Disease Clinical Trial

Official title: The Effect of a Renal Specific Oral Nutritional Supplement on Nutritional Status and Other Outcomes

Status Completed

Clinical Trial Summary

The study objective is to evaluate if a renal specific oral nutrition supplement (ONS) aids in maintaining nutritional status.

Clinical Trial Description

This study is an unblinded, prospective, multicenter, single arm study in Taiwan. Eligible subjects (see inclusion and exclusion criteria in Section 5.2) will receive standard of care (which includes dietary counseling) and ONS supplementation (1-2 servings/day depending on subject's needs) for 24 weeks (6 months). A follow up visit (phone call/medical chart review) will occur 12 months after the study intervention has ended to collect mortality data, to determine whether or not dialysis was initiated, and if ONS use continued.

Subjects will be informed of the study results when available. Subjects may continue use of the commercially available study product if it is recommended by their nephrologist, primary care physician, dietitian, or if the subject chooses.

For this study enrollment is defined as when the subject is stratified and begins to consume the study product (Study Visit 1, Month 0).

The target population described above may be stratified into the following groups (n=18 evaluable/group):

1. Male CKD Stage 3b-5 without T2DM

2. Male CKD Stage 3b-5 with T2DM

3. Female CKD Stage 3b-5 without T2DM

4. Female CKD Stage 3b-5 with T2DM

In addition, for those subjects enrolled, retrospective data (previous 6 to 12 months) identical to the study variables will be collected. Retrospective data collection will focus on the following measures, however, all data points are not expected to be available:

• Serum albumin

• SGA

• Compliance to protein intake guidelines

• Compliance to energy intake guidelines

• Hand grip strength

• Anthropometrics (weight, height, BMI)

• Quality of Life (WHOQOL-BREF Taiwan Version)

• eGFR (whichever equation is used as standard of care)

• Serum creatinine

• Proteinuria (retrospective - if available on medical records)

• BUN

• Body composition data from BIA (especially fat mass and muscle mass, units or exact terminology will be model specific)

• C reactive protein (CRP)

• Blood chemistries, ;

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

• NCT number: NCT02046746
• Study type: Interventional
• Source: Abbott Nutrition
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Completion date: May 2017