Clinical trial NCT04618952: Effect of Calcium- D Supplement on Hypertension
Official title: The Effect of Calcium-D Supplements on the Blood Pressure of Postmenopausal Women, Myth or Reality ? A Triple-blind Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: hypertension
calcium-D
ambulatory blood pressure monitoring
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2020-11-06
Enrollment: 98
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: block
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Mean systolic blood pressure in 24 hours
timeFrame: 60 days
measure: Mean diastolic blood pressure in 24 hours
timeFrame: 60 days
measure: Blood pressure dipping at night
timeFrame: 60 days
Secondary outcomes:
measure: Effect of amlodipine on the effect of calcium-D supplements
timeFrame: 60 days
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Professor Kojuri cardiology clinic
state: Fars
city: Shiraz
country: Iran, Islamic Republic of
facility: Cardiology Ward Shiraz University of Medical Sciences
state: Fars
city: Shiraz
country: Iran, Islamic Republic of
facility: Education Developmen Center
state: Fars
Study officials:
References:
citation: 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.