Status:
COMPLETED
Effect of Phosphorus Additives on the Metabolome in Healthy Adults
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Metabolic Syndrome
Insulin Sensitivity
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
This study evaluates the effect of phosphorus supplementation on the human metabolome. The investigators will do so by conducting a cross-over study in healthy adults consuming a study diet (normal di...
Detailed Description
Phosphorus is an essential micronutrient involved in a number of key biological processes. Excess phosphorus intake is linked to hypertension, heart failure, and disorders of bone and mineral metaboli...
Eligibility Criteria
Inclusion
- healthy volunteers, aged 18 - 45 years with normal kidney function (estimated glomerular filtration rate \> 60 ml/min/1.73m2).
Exclusion
- abnormal urinalysis-presence of hematuria, proteinuria, or leukocyturia. pregnancy or breast-feeding
- Medical conditions impacting phosphate metabolism-primary hyperparathyroidism; gastrointestinal malabsorption disorders such as Crohn's Disease, ulcerative colitis, celiac disease, or liver dysfunction; hyper- or hypothyroidism; irregular menses for female subjects.
- Medications known to affect phosphorus metabolism- current use of phosphorus supplements, high-dose or activated vitamin D compounds, regular antacid or laxative use, anticonvulsants.
- Hyper- or hypophosphatemia (≥ 4.6 mg/dl or ≤ 2.5 mg/dl respectively), hyper- or hypocalcemia (≥ 10.6 or ≤ 8.5 mg/dl respectively), or severe anemia (hemoglobin \< 8 g/dl for women and \< 9 g/dl for men), hyperkalemia (potassium \> 5.0 mmol/L).
Key Trial Info
Start Date :
June 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03841786
Start Date
June 28 2019
End Date
September 15 2022
Last Update
December 29 2022
Active Locations (1)
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1
University of Alabama
Birmingham, Alabama, United States, 35294