NCT03569410

Brief Summary

This study is a prospective open label clinical trial comparing serum albumin levels and total protein intake in the peritoneal dialysis patient population. A total of 60 patients were enrolled, 16 chose to be in the natural food group and 44 in the supplement group. 4 were lost to follow-up in the supplement group leading to an n of 40. Both groups were educated by dietitians on how to increase their protein intake to a goal of 1.4g/kg/day. The groups were followed for 3 months with protein intake calculated according to the patient's food diaries. Patient demographics and characteristics were compared in both groups.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 26, 2018

Completed
Last Updated

June 26, 2018

Status Verified

June 1, 2018

Enrollment Period

4 months

First QC Date

May 22, 2018

Last Update Submit

June 22, 2018

Conditions

Peritoneal Dialysis ComplicationHypoalbuminemiaMalnutrition

Keywords

peritoneal dialysisalbuminend stage renal disease

Outcome Measures

Primary Outcomes (1)

  • Serum Albumin Levels

    serum levels of albumin

    After three months of intervention.

Secondary Outcomes (3)

  • Serum Phosphorus levels

    At Month 0, 1, 2, and 3

  • Goal protein intake

    At Month 0, 1, 2, and 3

  • Serum albumin levels

    At Month 0, 1, 2, and 3

Study Arms (2)

Supplement Group

ACTIVE COMPARATOR

The protein supplement group was instructed by their dietician in how many protein supplements to consume in addition to their natural food intake in order to reach their goal protein intake.

Behavioral: increase protein intake via protein supplements

Natural Food Group

EXPERIMENTAL

The Natural food group was instructed by their dietician in how much additional protein rich foods to eat in order to reach their goal protein intake.

Behavioral: increased protein intake via natural foods

Interventions

increased protein intake via natural foodsBEHAVIORAL

Patients had to eat 1.4g/kg/day of natural protein.

Natural Food Group
increase protein intake via protein supplementsBEHAVIORAL

Patients ate enough protein supplements in addition to their regular diet to reach eat 1.4g/kg/day of protein intake.

Supplement Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age over 18 years
  • Initiation of peritoneal dialysis for at least a one-month time period, with the expectation to stay on peritoneal dialysis for the next 3 months
  • Independence with all activities of daily living (especially being able to cook)

You may not qualify if:

  • Age under 18 years
  • Expectation of termination of peritoneal dialysis within 3 months of entering the study
  • Life expectancy less than three months
  • Termination of life or peritoneal dialysis during the study period
  • Patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Riverside Medical Center

Riverside, California, 92505, United States

Location

Related Publications (3)

  • Jeloka TK, Dharmatti G, Jamdade T, Pandit M. Are oral protein supplements helpful in the management of malnutrition in dialysis patients? Indian J Nephrol. 2013 Jan;23(1):1-4. doi: 10.4103/0971-4065.107185.

    PMID: 23580797BACKGROUND

  • Cano N, Fiaccadori E, Tesinsky P, Toigo G, Druml W; DGEM (German Society for Nutritional Medicine); Kuhlmann M, Mann H, Horl WH; ESPEN (European Society for Parenteral and Enteral Nutrition). ESPEN Guidelines on Enteral Nutrition: Adult renal failure. Clin Nutr. 2006 Apr;25(2):295-310. doi: 10.1016/j.clnu.2006.01.023. Epub 2006 May 12.

    PMID: 16697495BACKGROUND

  • Clinical practice guidelines for nutrition in chronic renal failure. K/DOQI, National Kidney Foundation. Am J Kidney Dis. 2000 Jun;35(6 Suppl 2):S17-S104. doi: 10.1053/ajkd.2000.v35.aajkd03517. No abstract available.

    PMID: 10895784BACKGROUND

MeSH Terms

Conditions

HypoalbuminemiaMalnutritionKidney Failure, Chronic

Condition Hierarchy (Ancestors)

HypoproteinemiaBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesNutrition DisordersNutritional and Metabolic DiseasesRenal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Susan Sun, MD

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Open-label prospective clinical trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2018

First Posted

June 26, 2018

Study Start

October 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 1, 2018

Last Updated

June 26, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)