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Effect of Calcium- D Supplement on Hypertension

NCT ID: NCT04618952

Last Updated: 2020-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-09-01

Brief Summary

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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

Detailed Description

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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

Conditions

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Hypertension

Keywords

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hypertension calcium-D ambulatory blood pressure monitoring

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

block
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Group A and group B

Study Groups

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treatment

patients received calcium D

Group Type ACTIVE_COMPARATOR

Calcium D

Intervention Type DRUG

calcium D supplementation given to postmenopausal females

control

patients received placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Calcium D

calcium D supplementation given to postmenopausal females

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Shiraz University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Javad Kojuri

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Professor Kojuri cardiology clinic

Shiraz, Fars, Iran

Site Status

Cardiology Ward Shiraz University of Medical Sciences

Shiraz, Fars, Iran

Site Status

Education Developmen Center

Shiraz, Fars, Iran

Site Status

Countries

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Iran

References

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Sharifi F, Heydarzadeh R, Vafa RG, Rahmani M, Parizi MM, Ahmadi A, Zamiri B, Montaseri M, Kojuri J. The effect of calcium and vitamin D supplements on blood pressure in postmenopausal women: myth or reality? Hypertens Res. 2022 Jul;45(7):1203-1209. doi: 10.1038/s41440-022-00930-3. Epub 2022 May 13.

Reference Type DERIVED
PMID: 35562420 (View on PubMed)

Other Identifiers

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IR.SUMS.MED.REC.1398.215

Identifier Type: -

Identifier Source: org_study_id