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| Name | Class |
|---|---|
| University of Copenhagen | OTHER |
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This clinical trial aims to investigate and test the effect of an acid/base diet in chronic kidney disease (CKD) patients, CKD stage 4 and 5. The trial is guided by the hypothesis that an acid/base diet will reduce the degree of acidosis and simultaneously reduce the need for bicarbonate supplements.
Observational studies indicate that diets with a low "potential renal acid load (PRAL)" is associated with a lower serum-bicarbonate value. Therefore, we aim to investigate this association through an interventional study design.
Participants will be asked to follow a restricted diet with a low "PRAL" during a 6-week trial divided into three periods: two-week of free-living control, two-weeks of intervention, and a two-week free-living follow-up.
The PRAL calculation tool will be used to create a diet low in acid and to develop individualized diet plans for each patient. The diet will comply with Danish national guidelines on threshold for potassium and protein, due to the high risk of hyperkalemia in CKD patients. The patients will be asked to document their food and drink intake by taking pictures of their plates and cups before and after a meal, over a 24-hour period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low PRAL diet | Experimental | Experimental: Low PRAL diet Crossover design: 1 arm consisting of three consecutive periods of two weeks (control, intervention and follow up). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low PRAL | Other | Two weeks on a low PRAL diet compared to 2 week free living |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma-total carbon dioxide (CO2) | mmol/l | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma-alkaline phosphatase | U/l | 6 weeks |
| Plasma-sodium ion | mmol/l | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma-Potassium | mmol/l | 6 weeks |
| Plasma-calcium | mmol/l | 6 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Louise H Salomo, Doctor Med | Contact | 48293392 | louise.havkrog.salomo@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Lisbet Brandi, Doctor Med | Nordsjaellands Hospital | Principal Investigator |
| Jens R Andersen, As. prof. | University of Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nordshjaellands Hospital | Recruiting | Hillerød | 3400 | Denmark |
sharing is not currently possible recording to legislation and consent form.
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| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D000138 | Acidosis |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Single Group Assignment
Crossover design: 1 arm consisting of three consecutive periods of two weeks (control, intervention and follow up).
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| Plasma-creatinine | umol/l | 6 weeks |
| Plasma-parathyroid hormone | pmol/l | 6 weeks |
| Plasma-carbamide | mmol/l | 6 weeks |
| Plasma-albumin | g/l | 6 weeks |
| Urine-phosphorous | mmol/d | 6 weeks |
| Urine-sodium | mmol/d | 6 weeks |
| Urine-potassium | mmol/d | 6 weeks |
| Urine-carbamide | mmol/d | 6 weeks |
| Urine-albumin | mg/d | 6 weeks |
| Urine-magnesium | mmol/d | 6 weeks |
| Urine-creatinine | mmol/d | 6 weeks |
| Urine-calcium | mmol/d | 6 weeks |
| Total acid excretion in urine | mmol/d | 6 weeks |
| Urine-pH | pH | 6 weeks |
| Urine ammonium-ion (NH4+) excretion | mmol/d | 6 weeks |
| Urine net acid excretion | mmol/d | 6 weeks |
| Urine bicarbonate | mmol/l | 6 weeks |
| Plasma-magnesium |
mmol/l |
| 6 weeks |
| Plasma-inorganic phosphorous | mmol/l | 6 weeks |
| D052801 | Male Urogenital Diseases |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |