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No Patient recruitment
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| Name | Class |
|---|---|
| Clinact | OTHER |
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The objective of this unblinded study is to assess the nutritional effects of a 12 weeks administration of the specific enteral nutrition (SEN) RealDiet®Renal pockets, as well as the impact on the patients' quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RealDiet®Renal enteral nutrition | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RealDiet®Renal | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of serum prealbumin and albumin. | Evaluate during 3 months specific enteral nutrition (SEN) treatment, and 3 months after treatment interruption, the effects of the study product on the evolution of serum prealbumin and albumin. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of nutritional status during 3 months of enteral nutrition, and during 3 months after end of treatment. | 6 months | |
| Evolution of quality of life during 3 months of enteral nutrition, and during 3 months after end of treatment. | 6 months |
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Inclusion Criteria:
Chronic kidney disease patient on hemodialysis for at least 3 months, with a minimum of three hemodialysis sessions of 4 hours per week
Patients aged 18 years
Written, free and informed consent given by the Patient
Patient insured under the social security system or equivalent
Patients who did not receive enteral nutrition during the 3 months preceding inclusion ; taking an oral nutritional supplement, or per-dialytic parenteral nutrition or total parenteral nutrition is not a criterion of non-inclusion
Patient in a state of malnutrition
defined by the presence of at least 3 out of 5 of the following criteria :
and
presenting
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lactalis | Retiers | 35240 | France |
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| Evolution of tolerance of study product during 3 months of enteral nutrition. | 3 mois |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D044342 | Malnutrition |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001519 | Behavior |
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