Effect of Calcium- D Supplement on Hypertension

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04618952
• Other study ID #: IR.SUMS.MED.REC.1398.215
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2019
• Est. completion date: September 1, 2020

Study information

• Verified date: November 2020
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: September 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Calcium D
calcium D supplementation given to postmenopausal females
• Placebo
Placebo

Locations

Country	Name	City	State
Iran, Islamic Republic of	Cardiology Ward Shiraz University of Medical Sciences	Shiraz	Fars
Iran, Islamic Republic of	Education Developmen Center	Shiraz	Fars
Iran, Islamic Republic of	Professor Kojuri cardiology clinic	Shiraz	Fars

Sponsors (1)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean systolic blood pressure in 24 hours	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	60 days
Primary	Mean diastolic blood pressure in 24 hours	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	60 days
Primary	Blood pressure dipping at night	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	60 days
Secondary	Effect of amlodipine on the effect of calcium-D supplements	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	60 days