Impact of Lowering Phosphate Additive Intake on Metabolism and Cardiovascular Health in Community… (NCT02620449) | Clinical Trial Compass
CompletedNot Applicable
Impact of Lowering Phosphate Additive Intake on Metabolism and Cardiovascular Health in Community-Living Adults
United States50 participantsStarted 2015-08-28
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* (i.) Inclusion criteria for healthy volunteers: ≥18 years of age, normal kidney function (eGFR \> 60 and normal urinalysis).
Exclusion Criteria:
* 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 met…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in circulating fibroblast growth factor 23 (FGF23) concentrations