Trial Outcomes & Findings for Vitamin D Deficiency in Patients With Hypertension (NCT NCT00974922)

Results Overview

The primary endpoint was changes from baseline in 24-hour mean diastolic BP on aliskiren versus vitamin D3 in hypertensive patients with vitamin D deficiency.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

40 participants

Primary outcome timeframe

six weeks

Results posted on

2018-03-09

Participant Flow

Study initiated in 2010, study terminated prematurely by the sponsor in December 2011.

Participant milestones

Participant milestones
Measure	Aliskiren and Vitamin D3 AND Aliskiren Versus Vitamin D3 Study stopped prematurely. Intervention groups combined because data were never unblinded.
Overall Study STARTED	40
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	24

Reasons for withdrawal

Reasons for withdrawal
Measure	Aliskiren and Vitamin D3 AND Aliskiren Versus Vitamin D3 Study stopped prematurely. Intervention groups combined because data were never unblinded.
Overall Study study terminated	24

Baseline Characteristics

Vitamin D Deficiency in Patients With Hypertension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aliskiren Versus Vitamin D3 AND Aliskiren and Vitamin D3 n=40 Participants Two weeks of single-blind placebo, followed by randomized in a double-blind fashion to aliskiren 150 mg to 300 mg or Vitamin D3 (3000 I.U.) once daily for 6 weeks. Aliskiren 150-300 mg orally once daily and Vitamin D3 3000 IU in combination once daily for 6 weeks.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	36 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age, Continuous	54.85 years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: six weeks

Population: Study was never completed due to early termination of the trial by sponsor. Data were never analyzed because group assignment was never un-blinded and data lacked any scientific utility.

The primary endpoint was changes from baseline in 24-hour mean diastolic BP on aliskiren versus vitamin D3 in hypertensive patients with vitamin D deficiency.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Population: Study was never completed due to early termination of the trial by sponsor. Data were never analyzed because group assignment was never un-blinded and data lacked any scientific utility.

Outcome measures

Outcome data not reported

Adverse Events

Aliskiren Versus Vitamin D3 AND Aliskiren and Vitamin D3

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. William White

UCHC

Phone: 860-679-2104

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place