Effect of Oral Nutritional Supplementation Combined With Impedance Vectors

NACompletedINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

January 1, 2017

Primary Completion Date

June 30, 2017

Study Completion Date

June 30, 2017

Conditions
Chronic Kidney Disease Requiring Chronic DialysisOverhydrationUndernutrition
Interventions
DIETARY_SUPPLEMENT

Proteinex and Enterex DBT Victus Laboratories

The supplement was provided five days per week. Three days a week, the supplement was given at the beginning of the HD session and the patients were instructed to consume it slowly during the next 3 hours. The remaining two days, the supplement was consumed at home and instructed to be consumed between meals. The ONS consisted of one can of polymeric formula (Enterex DBT, Victus Laboratories) and 5.6 g of a protein powder supplement (Proteinex, Victus Laboratories). The final mixture provided 240 kcal, 17 g protein, 8.1 g lipids, 25 g carbohydrates, 4 g dietary fiber, 201 mg sodium, 490 mg calcium, 356 mg phosphorus and 371 mg potassium

PROCEDURE

Dry weight adjustment through BIVA

Those participants with post-dialysis vectors located within the 50 or 75% ellipses, were considered to be in dry weight, so they did not require any fluid removal adjustment. However, participants with vectors outside the 75% ellipse were considered overhydrated or dehydrated and dry weight was adjusted. In these patients, if the vectors fell outside the 75% ellipse but within the 95%, above or below the major axis, the established dry weight was adjusted by 0.5 Kg. If the vectors fell outside the 95% ellipse, the weight was adjusted by 1.0 Kg.

Trial Locations (1)

76000

HD unit of the Social Security Institute for Government Employees (ISSSTE as per initials in Spanish, Querétaro

All Listed Sponsors
collaborator

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

OTHER

collaborator

Indiana University School of Medicine

OTHER

collaborator

Ball State University

OTHER

lead

Universidad Autonoma de Queretaro

OTHER

NCT05288101 - Effect of Oral Nutritional Supplementation Combined With Impedance Vectors | Biotech Hunter | Biotech Hunter