Phase 3
Completed N=242
Study of Vitamin D and Uric Acid Lowering on Kidney and Blood Vessel Function
Renal Function · Endothelial Function · Blood Pressure · Overweight
Source: ClinicalTrials.gov NCT01320722 ↗
Enrolled (actual)
242
Serious AEs
5.1%
Results posted
Jun 2017
Primary outcomePrimary: Change in Renal Plasma Flow (RPF) in Response to Captopril in High Sodium Balance [Vitamin D] — 35.7; 35.9 mL/min per 1.73 m^2 — p=0.72
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The investigators hypothesize that, among non-hypertensive overweight and obese individuals, treatment of vitamin D deficiency and lowering uric acid concentrations (by either xanthine oxidase inhibition or increased renal excretion) will attenuate renin angiotensin system (RAS) activation, improve endothelial function, and lower blood pressure.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Renal Plasma Flow (RPF) in Response to Captopril in High Sodium Balance [Vitamin D] |
35.7; 35.9 | 0.72 |
| PRIMARY Plasma Renin Activity (PRA) [Vitamin D] |
0.36; 0.44 | 0.77 |
| PRIMARY Angiotensin II (ATII) Concentration [Vitamin D] |
19.5; 19.7 | 0.57 |
| PRIMARY Change in Renal Plasma Flow (RPF) Response to Captopril in High Sodium Balance [Uric Acid] |
33; 36; 30 | 0.8 |
| PRIMARY Plasma Renin Activity (PRA) [Uric Acid] |
0.4; 0.3; 0.2 | 0.6 |
| PRIMARY Angiotensin II (ATII) Concentration [Uric Acid] |
20.3; 21.4; 19.1 | 0.3 |
| SECONDARY Change in Endothelium-Dependent Vasodilation (EDV) |
6.3; 7.9; 7.4; 7.6; 6.5; 6.1 | 0.35 |
| SECONDARY Mean 24-Hour Ambulatory Blood Pressure (ABP) |
120.4; 123.7; 126.9; 124.1; 122.4; 71.6 | 0.92 |
| SECONDARY Mean 24-Hour Ambulatory Blood Pressure (ABP) Nocturnal Dipping |
7.3; 7.8; 8.4; 7.5; 9.4; 7.5 | 0.98 |
Eligibility Criteria
Inclusion Criteria
- 25(OH)D < 20 ng/mL OR Uric acid ≥ 5 mg/dL
- Age ≥ 18, ≤ 75 years
- Body Mass Index (BMI) ≥ 25 kg/m^2
Exclusion Criteria
- Hypertension, or on BP-lowering medicine
- Diabetes
- Coronary Heart Disease
- estimated glomerular filtration rate (EGFR) <60 mL/min
- Kidney stones
- Active cancer (except non-melanoma skin cancer)
- Pregnant
- Taking vitamin D supplements and unwilling to stop
- Osteoporosis
- Hypo- or hypercalcemia
- Hypo- or hyperphosphatemia
- Known allergy to angiotensin-converting enzyme (ACE)-inhibitors
- Taking medication for hyperuricemia
- Gout, anemia, cirrhosis, active/chronic hepatitis, abnormal aspartate aminotransferase (AST), alanine aminotransferase (ALT) or total bilirubin levels, or anemia
- Known allergy to either allopurinol or probenecid
- Current use of didanosine, azothioprine, methotrexate, ketoprofen, ketorolac, mycophenolate, or ACE-inhibitors
Data sourced from ClinicalTrials.gov (NCT01320722). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.