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

Primary Purpose

Chronic Kidney Disease

Status

Completed

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Oral Nutritional Supplement (ONS)

About this trial

This is an interventional treatment trial for Chronic Kidney Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subject, or subject's legally acceptable representative (LAR), has voluntarily signed and dated an informed consent form (ICF), approved by an IEC/IRB, and provided Health Insurance Portability and Accountability Act (HIPAA)
Subject is >18 years of age.
Subject has been diagnosed with Chronic Kidney Disease (CKD) and is classified as being between Stages 3b to 5.
Subject has an eGFR 45 and 10 ml/min/1.73m2 at screening.
Subject is a male or non-pregnant female at least six weeks postpartum and non-lactating.
Subject with CKD is either:
- not diagnosed with Type 2 Diabetes Mellitus (T2DM) OR
- diagnosed with T2DM and had no changes in glycemic medication (dose or type) for at least 2 months prior to screening
Subject has a serum albumin 3.0 g/dl at screening.
Subject has a BMI 30 kg/m2.
If diagnosed with T2DM, subject has A1c level 9.0% at screening.
Subject is not scheduled or expected to receive dialysis in the next 18 months.
Subject's life expectancy is 18 months determined by the study physician.
Subject is willing to follow the protocol as described.
With regard to ONS use the subject must qualify as one of the following:
1. be naïve to ONS
2. if the subject is already prescribed another ONS that is not the study product, and they have consumed 8 servings over the last 28 days prior to screening, they will undergo a washout period (3 weeks)
3. if the subject is already prescribed the study product, and they have consumed ≤ 8 servings over the last 28 days prior to screening, or have poor daily compliance (< 75%), they will undergo a washout period (3 weeks)
4. if the subject is already prescribed the study product, and they have been consuming 1-2 servings daily, with >75% compliance, for < 3 months, they do not require a washout period, and can be retrospectively included in the study protocol (provided proper records can be obtained)

Exclusion Criteria:

Subject has type 1 diabetes.
Subject is considered malnourished (SGA = 1 to 3).
Subject has received intravenous albumin treatment within the last 6 months.
Subject has overt symptomatic peripheral neuropathy, retinopathy, or autonomic neuropathy.
Subject has poorly controlled chronic hypertension
Subject has had major surgery, inpatient or outpatient, requiring >7 days of hospitalization in the last 3 weeks prior to screening visit,
Subject has a known chronic/contagious infectious disease, clotting or bleeding disorder, active malignancy
Subject is missing, or has had an amputation of, a limb.
Subject has had a significant cardiovascular event
Subject has a known obstruction of the gastrointestinal tract, inflammatory bowel disease, short bowel syndrome or other forms of gastrointestinal disease
Subject is currently diagnosed with, or has a history of severe dementia or delirium, eating disorder, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures
Subject is currently consuming, or cannot refrain from taking, medications/dietary supplements/herbal preparations or substances,
Subject is known to be allergic or intolerant to any ingredient found in the study product.
Subject is considered unsuitable for the study based on the study physician's assessment.

Sites / Locations

Kaohsiung Medical University Hospital (KMUH)
Taipei Veterans General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oral Nutritional Supplement (ONS)

Arm Description

1-2 serving per day of a renal specific oral nutritional supplement

Outcomes

Primary Outcome Measures

Serum Albumin

Secondary Outcome Measures

Subjective Global Assessment

Dietary Intake Compliance

Hand Grip Strength

Appetite

Body Mass Index

Quality of Life

Full Information

NCT ID

NCT02046746

First Posted

January 24, 2014

Last Updated

August 29, 2017

Sponsor

Abbott Nutrition

1. Study Identification

Unique Protocol Identification Number

NCT02046746

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

November 2013 (undefined)

Primary Completion Date

May 2016 (Actual)

Study Completion Date

May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Abbott Nutrition

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed 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): Male CKD Stage 3b-5 without T2DM Male CKD Stage 3b-5 with T2DM Female CKD Stage 3b-5 without T2DM 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,

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Kidney Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

53 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oral Nutritional Supplement (ONS)

Arm Type

Experimental

Arm Description

1-2 serving per day of a renal specific oral nutritional supplement

Intervention Type

Other

Intervention Name(s)

Oral Nutritional Supplement (ONS)

Intervention Description

renal specific commercially available ONS

Primary Outcome Measure Information:

Title

Serum Albumin

Time Frame