Effect of Calcium- D Supplement on Hypertension

Shiraz University of Medical Sciences

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: Calcium D; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04618952

IR.SUMS.MED.REC.1398.215

Details and patient eligibility

About

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

Full 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

Enrollment: 98 patients

Sex: Female

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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98 participants in 2 patient groups, including a placebo group

treatment

Active Comparator group

Description:

patients received calcium D

Treatment:

Drug: Calcium D

control

Placebo Comparator group

Description:

patients received placebo

Treatment:

Drug: Placebo