Vitamin D Augmentation of Tekturna (Aliskiren) in Hypertension

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01472796
• Date of registration: 11/11/2011
• Prospective Registration: No
• Primary sponsor: Wayne State University
• Public title: Vitamin D Augmentation of Tekturna (Aliskiren) in Hypertension VDATH
• Scientific title: Vitamin D Augmentation of Tekturna (Aliskiren) in Hypertension (VDATH)
• Date of first enrolment: July 2011
• Target sample size: 92
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01472796
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Carol A Muzyk, CCRP

• Name: Carol A Muzyk, CCRP

• Name: John M Flack, M.D., M.P.H.
• Affiliation: Wayne State University, TRaCE Research Group

Key inclusion & exclusion criteria

Inclusion Criteria:

- Ages 30-74

- Systolic Blood Pressure 140-159 mm Hg and Diastolic Blood Pressure <100 OR Diastolic
Blood Pressure 90-99mm Hg and Systolic Blood Pressure <160mm Hg

- Vitamin D deficiency: Serum 25-OH D >= 10 ng/ml (25 nmol/L) to < 20 ng/ml (50
nmol/L)

- Not using any antihypertensive medication(s) for the previous 3 months

Exclusion Criteria:

- Cancer(other than skin) known HIV or other medical condition that might limit life
expectancy.

- Pregnant or nursing

- Know adverse reactions to DRI's

- Hepatitis or liver enzyme elevations > 1.5x normal

- Estimated glomerular filtration rate (EGFR) <50 ml/min/1.7m2

- Diabetes Mellitus

- Serum calcium > 10.5 mg/dl or history of hypercalcemia

- History of primary hyperparathyroidism

- Sarcoidosis or other granulomatous disease

- Taking > 500 mg/d of supplemental elemental calcium

- Taking any drugs that decrease absorption of vitamin D, ex:xenical

- Taking the drug cyclosporine

- Taking any antihypertensive medications in the previous 3 months

- History of kidney stones

- Planning to move > 50 miles in the next 9 months



Age minimum: 30 Years
Age maximum: 74 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Hypertension

Intervention(s)

Dietary Supplement: Vitamin D (cholecalciferol)

Drug: Tekturna(Aliskiren) plus placebo

Primary Outcome(s)

Change in Ambulatory Systolic Blood Pressure [Time Frame: from baseline (Week 10) to Week 18]

Secondary Outcome(s)

Change in cuff diastolic blood pressure [Time Frame: from baseline (week 10) to Week 18]

Change in non-invasively obtained measures of vascular function [Time Frame: from baseline (week 10) to Week 18]

Change in urinary angiotensinogen [Time Frame: from baseline (week 10) to Week 18]

Change in cuff systolic blood pressure [Time Frame: from baseline (Week 10) to Week 18]

Change in Urinary albumin:creatinine ratio [Time Frame: from baseline (week 10) to Week 18]

Change in ambulatory diastolic blood pressure [Time Frame: from baseline (Week 10) to Week 18]

Change in plasma isoprostanes [Time Frame: from baseline (week 10) to Week 18]

Change in plasma renin activity [Time Frame: from baseline (week 10) to Week 18]

Change in urinary nitric oxide metabolites [Time Frame: from baseline (week 10) to Week 18]

Secondary ID(s)

CSPP100AUS41T

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Novartis