Psychological Aspects and Patients Compliance to Restricted-protein Regimens in Chronic Kidney Disease (KetoPsy)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02345759
Recruitment Status : Recruiting
First Posted : January 26, 2015
Last Update Posted : January 25, 2017
Information provided by (Responsible Party):
Anemia Working Group Romania

Brief Summary:
Dietary management of CKD patients proved important to postpone dialysis. Long-term compliance to protein-restricted diets was discussed. Psychological aspects involved in certain dietary behaviour have never been studied.

Condition or disease
Psychological Characteristics Involved in Dietary Compliance

Detailed Description:

The interest in dietary management resurged, since the high prevalence of revealed a major impact not only on morbidity, mortality, social activities and patients' quality of life, but also on health budget.

Although protein-restricted diets are used for more than a century in patients with advanced Chronic Kidney Disease (CKD), their efficacy and safety is still debatable. Enough evidence has being accumulated on their role in postponing dialysis initiation in compliant patients. Consequently, the long-term compliance to the diet is discussed. Psychological aspects of compliant patients are certainly involved. Identification of certain psychological predictors of dietary compliance could help to select the patients who are more likely to be compliant and therefore to benefit from such an intervention. Moreover, short-term or long-term psychological intervention addressing these factors could increase patient long-term compliance.

Accordingly, we are aiming to evaluate psychological characteristics of Chronic Kidney Disease patients in relation with their compliance to protein-restricted regimens.

Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Psychological Aspects Related to Compliance of Patients on Restricted-protein Regimens in Chronic Kidney Disease
Study Start Date : January 2013
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Keto-diet group
Vegetarian very low protein regimen (0.3 g proteins/kg ideal body weight per day) supplemented with ketoanalogues of essential amino acids (Ketosteril®, Fresenius Kabi, Bad Homburg, Germany), 1 capsule for every 5 kg of ideal dry body weight per day.
Conventional LPD group
0.6 g/kg per day, including high biological value proteins

Primary Outcome Measures :
  1. Compliance to the protein-restricted diet [ Time Frame: 12 months ]
    The compliance to the diet is appreciated to be good if both the achieved protein intake and the achieved energy is in the range of ±10% of the recommended values.

Secondary Outcome Measures :
  1. Parameters related to renal function (The decline in glomerular filtration rate (GFR) GFR decline [ Time Frame: 12 months ]
    The decline in glomerular filtration rate (GFR)

  2. Psychological parameter - self-efficacy score [ Time Frame: 12 months ]
    Self-efficacy score derives from the self-efficacy scale.

  3. Nitrogen balance (Serum urea level) [ Time Frame: 12 months ]
    Serum urea level

  4. Metabolic acidosis (Serum bicarbonate level) [ Time Frame: 12 months ]
    Serum bicarbonate level

  5. Calcium-phosphorus metabolism abnormalities (Serum calcium) [ Time Frame: 12 months ]
    Serum calcium

  6. Calcium-phosphorus metabolism abnormalities (Serum phosphates level) [ Time Frame: 12 months ]
    Serum phosphates level

  7. Psychological parameter - illness perception (Sub-scores derived from illness perception questionnaire) [ Time Frame: 12 months ]
    Sub-scores derived from illness perception questionnaire: the higher this score, the worse is patient's perception on the disease.

  8. Mental status - vitality index [ Time Frame: 12 months ]
    Vitality score derived from mental component of SF-36

  9. Psychological parameter -mental score [ Time Frame: 12 months ]
    The mental score looks at depression. Psychological difficulties interfere with the initiation of compliance behaviours.

Other Outcome Measures:
  1. Safety parameters (Subjective Global Assessment, anthropometric markers, biochemical parameters, and serum total cholesterol) [ Time Frame: 12 months ]
    Parameters of nutritional status are predefined as safety parameters. Subjective Global Assessment anthropometric markers, and biochemical parameters

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All consecutive adult patients, with stage 4-5ND CKD (estimated glomerular filtration by MDRD formula of less than 30 mL/min per year) included in the dietary intervention program of "Dr Carol Davila" Teaching Hospital of Nephrology coming for the scheduled visits between January the 1st and June the 30th, 2014 will be considered eligible.

Those who will sign the informed consent will be included in the study; the specially-designed questionnaire will be administered. Simultaneously, their routine assesment, including the dietary compliance, manifestations of CKD and the nutritional status will be performed, as recommended by the Romanian Best Practice Guidelines for CKD [28].


Inclusion Criteria:

  • adult patients
  • stage 4+ CKD
  • good nutritional status (Subjective Global Assessment score A/B and serum albumin ≥3.5 g/dL)
  • declared potentially good compliance with a low protein diet and agreed to follow the monitoring schedule are considered for the program

Exclusion Criteria:

  • poorly controlled arterial blood pressure (≥145/85 mm Hg)
  • uncontrolled diabetes mellitus
  • other relevant comorbidities (heart failure, active hepatic disease, digestive diseases with malabsorption, inflammation/anti-inflammatory therapy)
  • uremic complications (pericarditis, polyneuropathy)
  • feeding inability (anorexia, nausea)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02345759

Contact: Liliana Garneata, MD, PhD +40722619358
Contact: Cristina Drugau

Spitalul Clinic de Nefrologie "Dr Carol Davila" Recruiting
Bucuresti, Romania, 010731
Contact: Liliana Garneata, MD, PhD    0722619358   
Contact: Cristina Drugau, MD   
Sub-Investigator: Cristina Drugau, MD         
Sub-Investigator: Gabriel Stefan, MD         
Sub-Investigator: Paula Larisa Luca, MD         
Sub-Investigator: Alexandra Stancu, MD         
Sponsors and Collaborators
Anemia Working Group Romania
Study Chair: Gabriel Mircescu, Professor of Nephrology Spitalul Clinic de Nefrologie "Dr Carol Davila"
Study Director: Liliana Garneata, MD, PhD Spitalul Clinic de Nefrologie "Dr Carol Davila"
Principal Investigator: Cristina Drugau, MD Spitalul Clinic de Nefrologie "Dr Carol Davila"
Principal Investigator: Evy Dehelean, Psychologist International Health Care Systems Romania

Responsible Party: Anemia Working Group Romania Identifier: NCT02345759     History of Changes
Other Study ID Numbers: AWG 5/2014
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: January 2017

Keywords provided by Anemia Working Group Romania:
CKD patients
protein-restricted diets
psychological aspects

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency