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Clinical Trials/NCT02047799
NCT02047799CompletedPhase 2

Effect of Vitamin D Supplementation on Blood Pressure in Elderly People

Universidad de Colima1 site in 1 country45 target enrollmentStarted: April 1, 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
45
Locations
1
Primary Endpoint
Difference of systolic and diastolic blood pressure

Study Overview

Brief Summary

The prevalence and incidence of cardiovascular disease (such as Hypertension) increases exponentially with age (McDermott, 2007;) These diseases account for 30% of the global mortality (WHO, 2011). Vitamin D (VD) insufficiency affects as many as half of otherwise healthy adults in developed countries (Holick, 2007). VD is implicated in the control of blood pressure (BP) through inhibition of the renin-angiotensin system (Yamshchikov, 2009), although the role of VD supplementation for prevention and treatment of the HTA is controversial.The purpose of this study was to investigate if VD supplement in elderly people reduces the levels of BP.

Detailed Description

Study population Adults aged ≥ 60 years with essential hypertension were recruited through nursing homes and physical activity groups in the state of Colima, México. 45 subjects were assessed for eligibility at our out-patient clinic. We excluded subjects with impaired renal or hepatic function; also subjects who had been treated with vitamin D within the last three months.

None were on hormone replacement therapy, but we included subjects on anti-hypertensive for more than 10 years and the dosages were unchanged during the study. Before randomization, two subjects withdrew the informed consent because of personal reasons, and two subjects were excluded due to the diagnosis of severe hypertension.

Design The design was a double-blind, placebo controlled randomized clinical trial. The participants were randomly assigned using a computer-generated randomization code into two groups: group 1 (calcitriol group)with 22 subjects whom were enrolled for 6 weeks of treatment with a daily dose of 1000 IU of cholecalciferol (administered as 1 capsule of 25 μg each) and group 2 with 23 subjects (control group) whom received a similar placebo tablet for also 6 weeks.

During treatment, nine subjects (20%) left the trial due to personal reasons. All patients provided written informed consent. The study was conducted in accordance with the Declaration of Helsinki II and the guidance on Good Clinical Practice (GCP). Approval was obtained from the bioethics committee of the Faculty of Medicine from the University of Colima (FM014/2012).

Measurement At the screening visit prior to randomization, subjects had a routine clinical examination and data concerning medical history. BP was measured 3 consecutive days at the same time, using a kit integrated aneroid sphygmomanometer with stethoscope (medimetrics 5769) with the patient seated and with at least 5 min rest. The subjects with average BP >140/90 mm Hg were included in the study.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
60 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Adults aged ≥ 60 years with essential hypertension.
  • •Subjects on anti-hypertensive for more than 10 years and the dosages were unchanged during the study.

Exclusion Criteria

  • •Subjects who had been treated with vitamin D within the last three months.
  • •None were on hormone replacement therapy.

Arms & Interventions

Control

Placebo Comparator

A daily dose of placebo (administered as 1 capsule )

Intervention: Control (Dietary Supplement)

Calcitriol

Active Comparator

A daily dose of 1000 IU of cholecalciferol (administered as 1 capsule of 25 μg each)

Intervention: Calcitriol (Dietary Supplement)

Outcomes

Primary Outcomes

Difference of systolic and diastolic blood pressure

Time Frame: 6 weeks

Difference between systolic and diastolic blood pressure before and after treatment.

Secondary Outcomes

  • Difference of Serum 25-Hidroxyvitamin-D(6 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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