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| Name | Class |
|---|---|
| Nordsjaellands Hospital | OTHER |
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The goal of this clinical trial is to learn about and test the effect of an acid/base diet, in chronic kidney patients with CKD stage 4 and 5 in an interventional study with a historical control.
The hypothesize is, that an acid/base diet will reduce the degree of acidosis and the need for oral bicarbonate supplements.
Observational studies indicate that diets with a low "potential renal acid load (PRAL)" is associated with a lower serum-bicarbonate value. The aim is to investigate this association with an interventional studydesign.
Participants will be asked to follow a restricted diet with a low "PRAL" during a 6 week trial divided in three periodes: two week free living control, two week intervention and a two week free living follow-up.
The PRAL calculation tool will be used to create a diet low in acid, based on this the patients will receive individual diet plans. The diet will comply with national treshold guidelines for potassium and protein, this is due to the high risk of hyperkalemia in patients with chronic kidney disease. 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 | 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 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 | Affiliation | Role |
|---|---|---|
| Jens Rikardt Andersen, MD, MPA | University of Copenhagen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nordshjaellands Hospital | Hillerød | 3400 | Denmark |
Currently no plans for sharing
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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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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 |
| Uirne-calcium | mmol/d | 6 weeks |
| Total acid excretion in urine | meqv/day | 6 weeks |
| Urine-pH | Units | 6 weeks |
| Urine NH4+ excretion | mmol/day | 6 weeks |
| Urine net acid excretion | meqv/day | 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 |