Effect of Vitamin D Supplementation on Blood Pressure in Elderly People

NCT ID: NCT02047799

Last Updated: 2017-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2013-06-30

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.

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.

Conditions

High Blood Pressure

Keywords

elderly people, high blood pressure, vitamin D.

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Calcitriol

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

Group Type: ACTIVE_COMPARATOR

Calcitriol

Intervention Type: DIETARY_SUPPLEMENT

Subjects whom were enrolled for 6 weeks of treatment with a daily dose of Calcitriol (1000 UI)

Control

A daily dose of placebo (administered as 1 capsule )

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: DIETARY_SUPPLEMENT

Subjects whom were enrolled for 6 weeks of treatment with a daily dose of Placebo

Interventions

Calcitriol

Subjects whom were enrolled for 6 weeks of treatment with a daily dose of Calcitriol (1000 UI)

Intervention Type: DIETARY_SUPPLEMENT

Control

Subjects whom were enrolled for 6 weeks of treatment with a daily dose of Placebo

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Colima

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jaime A Bricio Barrios

Role: PRINCIPAL_INVESTIGATOR

Carmen A Sánchez Ramírez, MD, PhD

Role: STUDY_DIRECTOR

Universidad de Colima

Alín J Palacios Fonseca, MS

Role: STUDY_CHAIR

Universidad de Colima

Mario del-Toro Equihua, PhD

Role: STUDY_CHAIR

Universidad de Colima

Locations

Facultad de Medicina-Universidad de Colima

Colima, , Mexico

Countries

Mexico

References

McDermott MM. The international pandemic of chronic cardiovascular disease. JAMA. 2007 Mar 21;297(11):1253-5. doi: 10.1001/jama.297.11.1253. No abstract available.

Reference Type: BACKGROUND

PMID: 17374819 (View on PubMed)

WHO, World Heart Federation, World Stroke Organization. Global atlas on cardiovascular disease prevention and control. The Atlas of Heart Disease and Stroke. World Health Organization, 2011;8-13

Reference Type: BACKGROUND

Holick MF, Smith E, Pincus S. Skin as the site of vitamin D synthesis and target tissue for 1,25-dihydroxyvitamin D3. Use of calcitriol (1,25-dihydroxyvitamin D3) for treatment of psoriasis. Arch Dermatol. 1987 Dec;123(12):1677-1683a.

Reference Type: BACKGROUND

PMID: 2825606 (View on PubMed)

Yamshchikov AV, Desai NS, Blumberg HM, Ziegler TR, Tangpricha V. Vitamin D for treatment and prevention of infectious diseases: a systematic review of randomized controlled trials. Endocr Pract. 2009 Jul-Aug;15(5):438-49. doi: 10.4158/EP09101.ORR.

Reference Type: BACKGROUND

PMID: 19491064 (View on PubMed)

Bricio-Barrios JA Rd, Palacios-Fonseca AJ MSc, Del Toro-Equihua M, Sanchez-Ramirez CA. Effect of Calcitriol Supplementation on Blood Pressure in Older Adults. J Nutr Gerontol Geriatr. 2016 Oct-Dec;35(4):243-252. doi: 10.1080/21551197.2016.1206499.

Reference Type: DERIVED

PMID: 27897610 (View on PubMed)

Other Identifiers

SanchezC

Identifier Type: -

Identifier Source: org_study_id