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Trial record 2 of 123 for:    hypertension "vitamin d"

Vitamin D Deficiency in Patients With Hypertension

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ClinicalTrials.gov Identifier: NCT00974922
Recruitment Status : Terminated (Administrative/Sponsor Business Decision - terminated - study was not completed)
First Posted : September 11, 2009
Results First Posted : March 9, 2018
Last Update Posted : March 9, 2018
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
William B. White, UConn Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Vitamin D Deficiency
Hypertension
Interventions Drug: Aliskiren
Dietary Supplement: Cholecalciferol
Dietary Supplement: Placebo
Enrollment 40
Recruitment Details Study initiated in 2010, study terminated prematurely by the sponsor in December 2011.
Pre-assignment Details  
Arm/Group Title Aliskiren and Vitamin D3 AND Aliskiren Versus Vitamin D3
Hide Arm/Group Description Study stopped prematurely. Intervention groups combined because data were never unblinded.
Period Title: Overall Study
Started [1] 40
Completed 16
Not Completed 24
Reason Not Completed
study terminated             24
[1]
Group assignment was never unblinded due to discontinuation of study; randomization info unavailable
Arm/Group Title Aliskiren Versus Vitamin D3 AND Aliskiren and Vitamin D3
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
Group assignment was blinded to the PI and was never unblinded due to the discontinuation of the study by the sponsor. Therefore we are unable to determine the number of participants in each group. No data analyses occurred due to lack of any scientific utility of the information.
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
<=18 years
0
   0.0%
Between 18 and 65 years
36
  90.0%
>=65 years
4
  10.0%
[1]
Measure Description: Data not analyzed by groups as group assignment was blinded (and never un-blinded due to discontinuation by the sponsor). There were 30 participants between 18 and 65 years, and 10 participants over 65 years.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants
54.85  (11.3)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
25
  62.5%
Male
15
  37.5%
[1]
Measure Description: Data not analyzed by groups as group assignment was blinded (and never un-blinded due to discontinuation by the sponsor). There were 25 females and 15 males in total randomized to the study.
1.Primary Outcome
Title Change From Baseline in Ambulatory Diastolic Blood Pressure
Hide Description 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.
Time Frame six weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Aliskiren Versus Vitamin D3 AND Aliskiren and Vitamin D3
Hide Arm/Group Description:

Phase I: Two weeks of single-blind placebo, followed by randomization in a double-blind fashion to aliskiren 150 mg to 300 mg or Vitamin D3 (3000 I.U.) once daily for 6 weeks.

Phase II: Aliskiren 150-300 mg orally once daily and Vitamin D3 3000 IU in combination once daily for 6 weeks.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Change From Baseline Blood Pressure Measurement in 24-hour Systolic BP, Changes in Awake and Sleep Systolic and Diastolic BP, and Changes From Baseline in Clinic Systolic and Diastolic BP.
Hide Description [Not Specified]
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Aliskiren Versus Vitamin D3 AND Aliskiren and Vitamin D3
Hide Arm/Group Description:

Phase I: Two weeks of single-blind placebo, followed by randomization in a double-blind fashion to aliskiren 150 mg to 300 mg or Vitamin D3 (3000 I.U.) once daily for 6 weeks.

Phase II: Aliskiren 150-300 mg orally once daily and Vitamin D3 3000 IU in combination once daily for 6 weeks.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse event data were collected throughout the duration of the study ~ 2 years, 6 months
Adverse Event Reporting Description Data not analyzed by groups as group assignment was blinded (and never un-blinded due to discontinuation by the sponsor).
 
Arm/Group Title Aliskiren Versus Vitamin D3 AND Aliskiren and Vitamin D3
Hide Arm/Group Description

Phase I: 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.

Phase II: Aliskiren 150-300 mg orally once daily and Vitamin D3 3000 IU in combination once daily for 6 weeks.

All-Cause Mortality
Aliskiren Versus Vitamin D3 AND Aliskiren and Vitamin D3
Affected / at Risk (%)
Total   0/40 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Aliskiren Versus Vitamin D3 AND Aliskiren and Vitamin D3
Affected / at Risk (%)
Total   0/40 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Aliskiren Versus Vitamin D3 AND Aliskiren and Vitamin D3
Affected / at Risk (%)
Total   0/40 (0.00%) 
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. William White
Organization: UCHC
Phone: 860-679-2104
Responsible Party: William B. White, UConn Health
ClinicalTrials.gov Identifier: NCT00974922     History of Changes
Other Study ID Numbers: 09-166-1
20090713 ( Other Identifier: UConn Health Center )
First Submitted: September 10, 2009
First Posted: September 11, 2009
Results First Submitted: December 14, 2016
Results First Posted: March 9, 2018
Last Update Posted: March 9, 2018