Impact of Lowering Phosphate Additive Intake on Metabolism and Cardiovascular Health in Community-Living Adults
Completed · Not applicable
Conditions studied: Healthy, Chronic Kidney Disease
In brief
The purpose of the study is to learn more about how common food additives can affect phosphorus metabolism in people with normal kidney function and people with chronic kidney disease.
Key facts
- Study ID
- NCT02620449
- Run by
- University of Alabama at Birmingham
- People needed
- 50
- Starts
- 2015-08-28
- Expected to finish
- 2020-03-30
- Last updated by the study team
- 2021-03-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- (i.) Inclusion criteria for healthy volunteers: ≥18 years of age, normal kidney function (eGFR > 60 and normal urinalysis).
You may not qualify if…
- Exclusion criteria for healthy volunteers will include:
- current smoking
- extreme obesity (BMI ≥ 35 kg/m2)
- pregnancy or breastfeeding
- conditions affecting phosphate metabolism (e.g., hyper- or hypothyroidism; irregular menses for menstruating women)
- current intake of medications that impact phosphate metabolism (high-dose vitamin D, chronic antacid use)
- current use of blood pressure medications
- abnormal serum phosphate (≥ 4.6 or < 2.5 mg/dl) or calcium levels (≥ 10.6 or < 8.5 mg/dl)
- severe anemia (hemoglobin < 8 g/dl for women and < 9 g/dl for men).
- Inability to receive weekly shipments of food at home.
- Requirement for any special diet other than a regular diet.
- Allergies to any foods in the standardized diets (ii.) Inclusion criteria for CKD patients: ≥18 years of age, eGFR 20-50 ml/min
- Exclusion criteria for CKD patients will include:
- clinical need for a low potassium, low sodium or low protein diet
- new or recent change (<3 months) in dosage of medications known to impact vascular reactivity
- current smoking
- poorly controlled hypertension (≥160/100 mmHg)
- extreme obesity (BMI ≥ 35 kg/m2)
- pregnancy or breastfeeding
- conditions affecting phosphate metabolism (e.g., hyper- or hypothyroidism)
- current intake of medications that impact phosphate metabolism (e.g., high-dose vitamin D)
- abnormal serum phosphate (≥ 4.6 or < 2.5 mg/dl) or calcium levels (≥ 10.6 or < 8.5 mg/dl)
- severe anemia (hemoglobin < 8 g/dl for women and < 9 g/dl for men).
- Inability to receive weekly shipments of food at home.
- Allergies to any foods in the standardized diets
Where it is running
- University of Alabama — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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