Effect of Vitamin D Supplementation on Blood Pressure in Elderly People

November 8, 2017 updated by: Universidad de Colima
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Once enrolled in the study groups, anthropometrics measurements were collected. The measurements performed were weight and height with light clothing and no shoes, and the indicator body mass index (kg/m2) was calculated. For the determination of serum 25(OH)D,two blood samples were collected in the morning after an overnight fast of minimum 8 h on the day of the randomization and at the end of the study.

The patients attended control visits every week for safety measures, adverse event registration and assessment of compliance.Returned pills were counted at each visit, and compliance was calculated as the percentage of used pills compared to the expected number.

Biochemistry Serum 25(OH)D concentration were measured with the use of competitive enzyme-linked immunosorbent assay (ELISA: immunodiagnostic, Bernheim, Germany) after solid-phase extraction (reference range: 17-53 pg/mL). The intra- and interassay CVs for the 2 Vitamin D metabolites were <7,0% and 9,0%, respectively.

Statistical Analysis The data were analyzed with the SPSS version 21. The variables studied were described as frequencies, percentages and as median (interquartile range); inferential statistics were performed with non parametric tests (Mann Whitney and related sample Wilcoxon test), and correlations between variables were analyzed by bivariate correlation analysis by Pearson's correlation. Statistical significance was set at a p value < 0.05.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Colima, Mexico, 28000
        • Facultad de Medicina-Universidad de Colima

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

58 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Calcitriol
A daily dose of 1000 IU of cholecalciferol (administered as 1 capsule of 25 μg each)
Dietary supplement: Calcitriol
Subjects whom were enrolled for 6 weeks of treatment with a daily dose of Calcitriol (1000 UI)
Placebo Comparator: Control
A daily dose of placebo (administered as 1 capsule )
Dietary supplement: Control
Subjects whom were enrolled for 6 weeks of treatment with a daily dose of Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference of systolic and diastolic blood pressure
Time Frame: 6 weeks
Difference between systolic and diastolic blood pressure before and after treatment.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference of Serum 25-Hidroxyvitamin-D
Time Frame: 6 weeks
Difference between 25-Hidroxyvitamin-D before and after treatment.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Colima

Investigators

  • Principal Investigator: Jaime A Bricio Barrios
  • Study Director: Carmen A Sánchez Ramírez, MD, PhD, Universidad de Colima
  • Study Chair: Alín J Palacios Fonseca, MS, Universidad de Colima
  • Study Chair: Mario del-Toro Equihua, PhD, Universidad de Colima

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

January 26, 2014

First Submitted That Met QC Criteria

January 26, 2014

First Posted (Estimate)

January 28, 2014

Study Record Updates

Last Update Posted (Actual)

November 13, 2017

Last Update Submitted That Met QC Criteria

November 8, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SanchezC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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