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Effect of Calcium- D Supplement on Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04618952
Recruitment Status : Completed
First Posted : November 6, 2020
Last Update Posted : November 9, 2020
Sponsor:
Information provided by (Responsible Party):
Javad Kojuri, Shiraz University of Medical Sciences

Brief 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

Condition or disease Intervention/treatment Phase
Hypertension Drug: Calcium D Drug: Placebo Phase 4

Detailed 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: block
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Group A and group B
Primary Purpose: Treatment
Official Title: The Effect of Calcium-D Supplements on the Blood Pressure of Postmenopausal Women, Myth or Reality ? A Triple-blind Randomized Clinical Trial
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : August 1, 2020
Actual Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: treatment
patients received calcium D
Drug: Calcium D
calcium D supplementation given to postmenopausal females

Placebo Comparator: control
patients received placebo
Drug: Placebo
Placebo




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   postmenopausal female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04618952


Locations
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Iran, Islamic Republic of
Professor Kojuri cardiology clinic
Shiraz, Fars, Iran, Islamic Republic of, 15758
Cardiology Ward Shiraz University of Medical Sciences
Shiraz, Fars, Iran, Islamic Republic of, 51318
Education Developmen Center
Shiraz, Fars, Iran, Islamic Republic of, 55318
Sponsors and Collaborators
Shiraz University of Medical Sciences
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Javad Kojuri, professor, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT04618952    
Other Study ID Numbers: IR.SUMS.MED.REC.1398.215
First Posted: November 6, 2020    Key Record Dates
Last Update Posted: November 9, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Results and article will be available

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Javad Kojuri, Shiraz University of Medical Sciences:
hypertension
calcium-D
ambulatory blood pressure monitoring
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs