Skip to main content
OpenTrials
Completed

NCT Number: NCT04618952

Effect of Calcium- D Supplement on Hypertension

Triple-blind randomized clinical trial was done on 98 hypertensive women of postmenopausal ages in 2019. The study was executed for 8 weeks with close follow up and , 24-hour Ambulatory blood pressure monitoring (ABPM) was used to record the initial and final blood pressures of all participants. Patients were randomized to calcium-D supplement and placebo

Completed

Looking for future studies?

Notify Me

Key information

Age range

40 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Cardiology Ward Shiraz University of Medical Sciences, Shiraz, Fars, Iran

Loading trial locations.

About this study

Triple-blind randomized clinical trial were performed on 98 hypertensive women of postmenopausal ages in 2019. They were randomly divided into a control group of 50 members and a treatment group of 48 members. Randomization was based on block randomization method with block size=2 and ratio 2:2 for drug and placebo. To achieve triple blinding, patients were divided into "A" and "B" groups(by the mentioned randomization method). "A" was assigned to treatment and "B" to placebo but this assignment was not revealed to the patients, trial conductors and result assessors till the end of data analysis.

Oral calcium-D supplements were given to the treatment group in the form of tablets named Vana Flex® from Vana Darou Gostar Co. (VDG Co.). Each tablet contained 500 milligrams of calcium carbonate and 200 international units (IU) of vitamin D3(cholecalciferol). The placebo pills for the control group were chose in a way that looked similar to the calcium-D tablets in shape and color. The placebo tablets we used in this trial were made up of magnesium stearate 0.2 %, starch 10%, avicel 30%, and lactose 60%. The calcium-D and placebo tablets were both packed identically in order to assure blindness and the patients were told to take one tablet per day. The treatment and placebo group started drugs beside their previous hypertension medications.

24-hour Ambulatory blood pressure monitoring (ABPM) was done primarily for all of the participants to record the initial blood pressure of patients and after completion of study period

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • postmenopausal female with hypertension
  • receiving antihypertensive drugs

Exclusion criteria

  • history of coronary artery disease
  • congestive heart failure
  • chronic renal disease
  • hypercalcemia
  • nephrolithiasis
  • any other contraindications of calcium use

Treatment and study plan

Calcium D

Drug

calcium D supplementation given to postmenopausal females

Placebo

Drug

Placebo

Primary outcomes

  1. Mean systolic blood pressure in 24 hours

    Time frame: 60 days

    24 hour holter monitoring was used to measure systolic blood pressure in automated measurement for 80 times at home, in millimeter of mercury and device reported the mean of these systolic pressures

  2. Mean diastolic blood pressure in 24 hours

    Time frame: 60 days

    24 hour holter monitoring was used to measure diastolic blood pressure in automated measurement for 80 times at home, in millimeter of mercury and device reported the mean of these diastolic pressures

  3. Blood pressure dipping at night

    Time frame: 60 days

    24 hour holter monitoring was used to measure mean systolic blood pressure in automated measurement for 80 times at home, in millimeter of mercury and device reported the mean of these systolic pressures, and comparing mean of systolic blood pressure at night and day, and dippers are those who have more than 10% drop in mean systolic blood pressure at nigh

Secondary outcomes

  1. Effect of amlodipine on the effect of calcium-D supplements

    Time frame: 60 days

    patients in study divided to two groups ,who received amlodipine or not and effect of calcium-D supplement, was compared between these two groups, by 24 hour holter monitoring of blood pressure

Sponsors and collaborators

Lead sponsor

Shiraz University of Medical Sciences

Other

Registry information

Official study title

The Effect of Calcium-D Supplements on the Blood Pressure of Postmenopausal Women, Myth or Reality ? A Triple-blind Randomized Clinical Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 6, 2020
Registry last updated
Nov 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.