Hypertension
Conditions
Keywords
hypertension, calcium-D, ambulatory blood pressure monitoring
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
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
Interventions
DRUGCalcium D
calcium D supplementation given to postmenopausal females
DRUGPlacebo
Placebo
Sponsors
Shiraz University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Group A and group B
Intervention model description
block
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean systolic blood pressure in 24 hours | 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 |
| Mean diastolic blood pressure in 24 hours | 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 |
| Blood pressure dipping at night | 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
| Measure | Time frame | Description |
|---|---|---|
| Effect of amlodipine on the effect of calcium-D supplements | 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 |
Countries
Iran
Outcome results
None listed