Short Term Cardiovascular Effects and Oxidative Status of Calcium and Vitamin D Supplementation of Postmenopausal Hypertensive Blacks Women

Sponsor

Yaounde Central Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04255992

Collaborator

(none)

Enrollment

Location

Arms

6.4

Actual Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to determine the effect of calcium and vitamin D supplementation on oxidative status and blood pressure profile of postmenopausal patients with high blood pressure in Yaoundé, Cameroon.

This study is a double-arm, double-blind, randomized and parallel clinical trial conducted at the Yaoundé Central Hospital

Condition or Disease	Intervention/Treatment	Phase
Hypertension Postmenopausal Disorder	Dietary Supplement: Calcium Arm Dietary Supplement: Vitamin D/Calcium	Phase 4

Detailed Description

Aim: to determine and compare the short term effect of calcium and vitamin D supplementation on oxidative status and blood pressure profile of postmenopausal patients with high blood pressure in Yaoundé, Cameroon.

Method: A double-arm, double-blind, randomized and parallel clinical trial conducted at the Yaoundé Central Hospital. Postmenopausal hypertensive blacks women who are taking taking antihypertensives drugs since 12 months,without diabetes mellitus or any inflammatory disease or hypercalcemia, are randomize into 2 groups. Depending on the group, the intervention consisted of the administration of Calcium 1000 mg daily or Vitamin D/Calcium 1000 mg/800 UI daily for 08 weeks. The endpoints were the nycthemeral blood pressure profile, pro oxidant marker (malondialdehyde) and anti-oxidant marker (Ferric reducing antioxidant).

Progress: Recruitment for this study was completed in May 2019 with 22 patients.

Study Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This study is a double blind, randomized, controlled parallel clinical trial conducted at the Yaounde central hospital, CameroonThis study is a double blind, randomized, controlled parallel clinical trial conducted at the Yaounde central hospital, Cameroon

Masking:

Double (Participant, Investigator)

Masking Description:

The double-blind model is applied to the study. Only the adjudicator, responsible for the distribution of medication knew the different regimes. Calcium and Vitamin D/Calcium were packaged in boxes of identical appearance and labeled for each participant by name and number of the randomization program. The randomization and packaging of the drugs was done by an investigator who had no clinical involvement.

Primary Purpose:

Treatment

Official Title:

Short Term Cardiovascular Effects and Oxidative Status of Calcium and Vitamin D Supplementation of Postmenopausal Hypertensive Blacks Women in Sub Saharan Africa

Actual Study Start Date :

Nov 1, 2018

Actual Primary Completion Date :

May 15, 2019

Actual Study Completion Date :

May 15, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Calcium arm 1000 mg Calcium tablet per day at 8am (+/- 1 hour) was add to the usual treatment for each patient. Patients are followed-up for a period of 08 weeks.	Dietary Supplement: Calcium Arm 1000 mg Calcium tablet / day will be added to the usual treatment for each patient for a period of 8 weeks.
Active Comparator: Vitamin D/Calcium 1000 mg/800UI of VitaminD/Calcium tablet per day at 8am (+/- 1 hour) was add to the usual treatment for each patient. Patients are followed-up for a period of 08 weeks.	Dietary Supplement: Vitamin D/Calcium 1000 mg/800UI of the association Vitamin D/Calcium tablet / day will be added to the usual treatment for each patient for a period of 8 weeks.

Arm

Intervention/Treatment

Active Comparator: Calcium arm

1000 mg Calcium tablet per day at 8am (+/- 1 hour) was add to the usual treatment for each patient. Patients are followed-up for a period of 08 weeks.

Dietary Supplement: Calcium Arm

1000 mg Calcium tablet / day will be added to the usual treatment for each patient for a period of 8 weeks.

Active Comparator: Vitamin D/Calcium

1000 mg/800UI of VitaminD/Calcium tablet per day at 8am (+/- 1 hour) was add to the usual treatment for each patient. Patients are followed-up for a period of 08 weeks.

Dietary Supplement: Vitamin D/Calcium

1000 mg/800UI of the association Vitamin D/Calcium tablet / day will be added to the usual treatment for each patient for a period of 8 weeks.

Outcome Measures

Primary Outcome Measures

Change in nycthemeral blood pressure profile (mmHg) [8 weeks]
Change in nycthemeral blood pressure profile from baseline to week 08. By using Arterial Blood Pressure Monitoring.

Secondary Outcome Measures

Change in serum concentration of oxidant marker: malondialdehyde (micromol/l) [8 weeks]
Change in concentration of oxidant marker from baseline to week 8. By spectrophotometer

Other Outcome Measures

Change in serum concentration of anti-oxidant markers: Ferric reducing antioxidant Power (micromol) [8 weeks]
Change in concentration of anti oxidant marker from baseline to week 8. By spectrophotometer

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 85 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Post menopausal hypertensive women since 12 months
On a stable antihypertensive therapies (determined by the investigator) for at least 3 months with no classes changes.
Before any study-specific procedure, the appropriate written informed consent must be obtained.

Exclusion Criteria:

Diabetes mellitus or inflammatory diseases
Hypercalcemia,
Side effects affecting life quality of patients (determined by the Data Safety Monitoring Board).
Withdrawal of consent