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| Name | Class |
|---|---|
| Servicio de Salud Metropolitano Oriente | UNKNOWN |
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The aim of the study is to demonstrate that a ketoacid supplement in patients with stage III to IV chronic renal failure, reduces the excretion of urinary urea nitrogen
Patients with an estimated glomerular filtration rate of less than 25 ml/kg/min, not on renal substitution therapy, without important concomitant diseases and aged between 40 and 70 years, will be invited to participate in the study. They will be randomly assigned to a group that will receive receive a supplement of ketoacids (Ketosteril) 1 tablet containing 630 mg of ketoacids every 5 kg of body weight and a diet containing 25 to 35 kcal/kg and 0.3 g/protein per day or to a group receiving placebo and a diet containing 25 to 35 kcal/kg and 0.6 g/protein per day. The intervention will last 16 weeks. At baseline and the end of the intervention a blood sample will be obtained to measure creatinine, urea nitrogen and cystatin C. Also a spot urine sample will be obtained to measure urea nitrogen and creatinine excretion. The compliance with the dietary prescription and the ketoacid or placebo supplement will be assessed every 2 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketoacid supplementation | Experimental | Will receive a ketoacid supplement containing 630 mg of ketoacids in a dose of 1 tablet every 5 kg of body weight |
|
| Placebo | Placebo Comparator | Will receive placebo tablets in a dose of 1 tablet every 5 kg of body weight |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketoacids | Dietary Supplement | Provision of 1 Tablet containing 630 mg of ketoacids every 5 kg of body weight during 16 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Estimated glomerular filtration rate | glomerular filtration rate estimated using the CKD-EPI formula for Cystatin-C | 16 weeks |
| Urinary urea nitrogen excretion | Measurement of urea nitrogen i na spot urine sample | 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Bunout, MD | INTA University of Chile | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital del Salvador | Santiago | Santiago Metropolitan | Chile |
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 29, 2019 | |
| Reset | Jul 26, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 29, 2019 | Jul 26, 2019 |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D007651 | Keto Acids |
| ID | Term |
|---|---|
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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Participants will be randomly assgned to receive the ketoacid supplement or placebo
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There will be no masking of the treatment arm for researchers
| Placebo | Dietary Supplement | Provision of placebo capsules similar to active supplement |
|
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |