Effect of Calcium- D Supplement on Hypertension

NCT04618952 | Completed Phase 4

• 1 other identifier: IR.SUMS.MED.REC.1398.215
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 3

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

Conditions

Hypertension

Keywords

hypertension; calcium-D; ambulatory blood pressure monitoring

Outcome Measures

Primary Outcomes (3)

• Mean systolic blood pressure in 24 hours

  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

  60 days

• Mean diastolic blood pressure in 24 hours

  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

  60 days

• Blood pressure dipping at night

  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

  60 days

Secondary Outcomes (1)

• Effect of amlodipine on the effect of calcium-D supplements

  60 days

Study Arms (2)

treatment

ACTIVE COMPARATOR

patients received calcium D

Drug: Calcium D

control

PLACEBO COMPARATOR

patients received placebo

Drug: Placebo

Interventions

Calcium D DRUG

calcium D supplementation given to postmenopausal females

treatment

Placebo DRUG

Placebo

control

Eligibility Criteria

• Age: 40 Years - 80 Years
• Gender Eligibility Details: postmenopausal female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• postmenopausal female with hypertension
• receiving antihypertensive drugs

You may not qualify if:

• history of coronary artery disease
• congestive heart failure
• chronic renal disease
• hypercalcemia
• nephrolithiasis
• any other contraindications of calcium use

Sponsors & Collaborators

• Shiraz University of Medical Sciences: lead

Study Sites (3)

Professor Kojuri cardiology clinic

Shiraz, Fars, 15758, Iran

Location

Cardiology Ward Shiraz University of Medical Sciences

Shiraz, Fars, 51318, Iran

Location

Education Developmen Center

Shiraz, Fars, 55318, Iran

Location

Related Publications (1)

• 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.

  PMID: 35562420 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Group A and group B
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: block

Study Record Dates

• First Submitted: October 30, 2020
• First Posted: November 6, 2020
• Study Start: January 1, 2019
• Primary Completion: August 1, 2020
• Study Completion: September 1, 2020
• Last Updated: November 9, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

IR (3)