Your session is about to expire
← Back to Search
Dietary Supplement
Dietary Phosphate Impact on Phosphate Overload
N/A
Recruiting
Led By Wanpen Vongpatanasin, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The randomized crossover trial will be performed on otherwise healthy subjects without diabetes mellitus, chronic kidney disease (CKD), preexisting cardiovascular disease, or treatment with any vasoactive agent that might alter cardiovascular responses to exercise.
Be older than 18 years old
Must not have
History of active malignancy
History of cardiopulmonary disease or chronic kidney disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial in mice shows that a high phosphate diet leads to reduced activity and metabolism. The results might not be relevant for humans.
Who is the study for?
This trial is for healthy adults without diabetes, chronic kidney disease, heart disease, or those on blood pressure medications. Participants should not be pregnant, have normal phosphate levels in their blood, and no history of psychiatric illness, active cancer or substance abuse including smoking.
What is being tested?
The study tests the effects of dietary phosphate (found in many foods) on exercise ability and belly fat. It compares taking sodium phosphate to sodium chloride (table salt), looking at how these supplements might affect physical activity and metabolism.
What are the potential side effects?
Potential side effects may include an imbalance of electrolytes due to high phosphate intake which can lead to issues with muscle function or cardiovascular health. Sodium intake could also impact blood pressure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am healthy without diabetes, kidney disease, heart disease, or taking heart-related meds.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of cancer.
Select...
I have a history of heart, lung, or kidney disease.
Select...
My kidney function is reduced.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
oxygen uptake (VO2) during peak exercise
Secondary study objectives
Cardiac output (CO)
Phosphocreatine (PCr) depletion
Resting ATP synthesis
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Sodium Phosphate (NaPO4) then sodium chloride (NaCl)Experimental Treatment2 Interventions
Participants will be asked to take 2 capsules daily of Sodium Phosphate (containing a total of 500 mg of Pi, 372mg of sodium) ) for 4 weeks during the high Pi phase (total Pi intake 1,200 mg/d). Then, participants will be asked to take 2 capsules of Sodium Chloride (NaCl, containing a total of 372mg of sodium) to match Na content to Sodium Phosphate without extra Pi daily for 4 weeks during the low Pi phase (total Pi intake = 700 mg/d).
Group II: NaCl then NaPO4Experimental Treatment2 Interventions
Participants will be asked to take 2 capsules daily of Sodium Chloride (NaCl, containing a total of 372mg of sodium) for 4 weeks during the low Pi phase (total Pi intake = 700 mg/d). Then, participants will be asked to take 2 capsules of Sodium Phosphate daily for 4 weeks Sodium Phosphate (containing a total of 500 mg of Pi, 372mg of sodium) for 4 weeks during the high Pi phase (total Pi intake 1,200 mg/d).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sodium Chloride
2003
Completed Phase 4
~2650
Find a Location
Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,088 Previous Clinical Trials
1,059,596 Total Patients Enrolled
Wanpen Vongpatanasin, MDPrincipal InvestigatorWanpen.Vongpatanasin@UTSouthwestern.edu
11 Previous Clinical Trials
681 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of cancer.I have diabetes or another long-term illness.I have a history of heart, lung, or kidney disease.I am healthy without diabetes, kidney disease, heart disease, or taking heart-related meds.I am taking medication for high blood pressure.My kidney function is reduced.
Research Study Groups:
This trial has the following groups:- Group 1: Sodium Phosphate (NaPO4) then sodium chloride (NaCl)
- Group 2: NaCl then NaPO4
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.