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Dietary Supplement
Diet A and Diet B for Moderate Chronic Kidney Disease
N/A
Waitlist Available
Led By Kathleen M Hill Gallant, PhD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hours
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new method to track calcium and phosphorus levels in people with kidney disease.
Eligible Conditions
- Chronic Kidney Disease
- Renal osteodystrophy
- Phosphorus and Calcium Imbalance
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Calcium Balance
Fractional Calcium Absorption
Fractional Phosphorus Absorption
+1 moreSecondary study objectives
Serum 1,25-dihydroxyvitamin D (1,25D)
Serum Intact Fibroblast Growth Factor 23 (iFGF23)
Serum Intact Parathyroid Hormone (iPTH)
Awards & 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: Sequence BExperimental Treatment2 Interventions
Low Phos crossover to High Phos
Group II: Sequence AExperimental Treatment2 Interventions
High Phos crossover to Low Phos
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Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,423 Previous Clinical Trials
1,619,782 Total Patients Enrolled
Indiana UniversityOTHER
1,035 Previous Clinical Trials
1,218,976 Total Patients Enrolled
Kathleen M Hill Gallant, PhDPrincipal InvestigatorUniversity of Minnesota
1 Previous Clinical Trials
19 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your vitamin D levels in your blood need to be higher than 20 ng/mL.You have a condition in your intestines that affects how your body absorbs nutrients, like celiac disease or having had part of your intestines removed.You have taken certain medications that affect calcium and phosphate levels in the past 30 days.Men or women between 30 and 75 years old of any race or ethnicity.You have a moderate kidney disease.Your blood phosphate levels have been higher than 5.5 mg/dL in the past 3 months.You are planning to start dialysis within the next 6 months.You have had high levels of calcium in your blood in the past 3 months.Your blood potassium level has been too high in the past 3 months.You have a serious health condition like diabetes or lupus that is not well managed.
Research Study Groups:
This trial has the following groups:- Group 1: Sequence A
- Group 2: Sequence B
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.
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