N/A
Completed N=18
The VALIDATE-D Study
Source: ClinicalTrials.gov NCT01635062 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcomePrimary: The Change in Circulating RAS Activity After Calcitriol/Placebo Therapy — 0; -1.3 ng/mL/h — p=0.69
Summary
The purpose of this study is to evaluate whether vitamin D receptor agonist therapy lowers renin-angiotensin system activity.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Change in Circulating RAS Activity After Calcitriol/Placebo Therapy |
0; -1.3 | 0.69 |
| SECONDARY Change in Renal Plasma Flow After Calcitriol/Placebo Therapy |
-16.4; -0.6 | 0.89 |
| SECONDARY Change in Urine Protein After Calcitriol/Placebo Therapy |
21.1; 8.1 | 0.80 |
Eligibility Criteria
Inclusion Criteria
- Type-Two Diabetes (treated with diet alone, with oral hypoglycemic agents, or with a single injection of basal insulin daily)
- Normal blood pressure, or Mild (Stage 1) Hypertension that is either untreated, or adequately treated with a single anti-hypertensive drug.
- Age >18 years and 60ml/min
- Normal laboratory values for: Complete blood count, sodium, potassium, glucose, liver enzymes, urinalysis
- Electrocardiogram without any signs of prior infarction, ventricular conduction abnormality, or supraventricular arrhythmia.
Exclusion Criteria
- Chronic Kidney Disease or eGFR 8.5%
- Type 1 diabetes
- Stage 2 or Stage 3 hypertension or the use of more than 1 antihypertensive drug
- Chronic inflammatory conditions (such as inflammatory bowel disease or arthritis) that are treated with prescribed doses of NSAIDs by a physician.
- The use of prescribed doses of potassium supplements.
- History of liver failure
- History of parathyroid or granulomatous disorders
- History of heart failure, cerebrovascular disease or coronary heart disease
- History of known microvascular complications of diabetes (including retinopathy, neuropathy, nephropathy)
- Illness requiring overnight hospitalization in the past 6 months
- Active tobacco or recreational drug use
- Pregnancy or current breast feeding
Data sourced from ClinicalTrials.gov (NCT01635062). 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.