NCT02047799

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 28, 2014

Completed
Last Updated

November 13, 2017

Status Verified

November 1, 2017

Enrollment Period

Same day

First QC Date

January 26, 2014

Last Update Submit

November 8, 2017

Conditions

High Blood Pressure

Keywords

elderly people, high blood pressure, vitamin D.

Outcome Measures

Primary Outcomes (1)

  • Difference of systolic and diastolic blood pressure

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

    6 weeks

Secondary Outcomes (1)

  • Difference of Serum 25-Hidroxyvitamin-D

    6 weeks

Study Arms (2)

Calcitriol

ACTIVE COMPARATOR

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

Dietary Supplement: Calcitriol

Control

PLACEBO COMPARATOR

A daily dose of placebo (administered as 1 capsule )

Dietary Supplement: Control

Interventions

CalcitriolDIETARY_SUPPLEMENT

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

Calcitriol
ControlDIETARY_SUPPLEMENT

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

Control

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Facultad de Medicina-Universidad de Colima

Colima, 28000, Mexico

Location

Related Publications (5)

  • 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.

    PMID: 17374819BACKGROUND

  • 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

    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.

    PMID: 2825606BACKGROUND

  • 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.

    PMID: 19491064BACKGROUND

  • 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.

    PMID: 27897610DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Calcitriol

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DihydroxycholecalciferolsHydroxycholecalciferolsCholecalciferolCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Jaime A Bricio Barrios

    PRINCIPAL INVESTIGATOR

  • Carmen A Sánchez Ramírez, MD, PhD

    Universidad de Colima

    STUDY DIRECTOR

  • Alín J Palacios Fonseca, MS

    Universidad de Colima

    STUDY CHAIR

  • Mario del-Toro Equihua, PhD

    Universidad de Colima

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2014

First Posted

January 28, 2014

Study Start

April 1, 2013

Primary Completion

April 1, 2013

Study Completion

June 1, 2013

Last Updated

November 13, 2017

Record last verified: 2017-11

Locations

ME(1)