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

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

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

Study Overview

• Status: Completed
• Conditions: Hypertension; Postmenopausal Disorder
• Intervention / Treatment: Dietary supplement: Calcium Arm; Dietary supplement: Vitamin D/Calcium

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 Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 4

Contacts and Locations

Study Locations

• Cameroon
  • Yaounde, Cameroon
    • Yaounde Central Hospital, Cardiology department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in nycthemeral blood pressure profile (mmHg)	Change in nycthemeral blood pressure profile from baseline to week 08. By using Arterial Blood Pressure Monitoring.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in serum concentration of oxidant marker: malondialdehyde (micromol/l)	Change in concentration of oxidant marker from baseline to week 8. By spectrophotometer	8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in serum concentration of anti-oxidant markers: Ferric reducing antioxidant Power (micromol)	Change in concentration of anti oxidant marker from baseline to week 8. By spectrophotometer	8 weeks

Collaborators and Investigators

• Sponsor: Yaounde Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): May 15, 2019
• Study Completion (Actual): May 15, 2019

Study Registration Dates

• First Submitted: February 3, 2020
• First Submitted That Met QC Criteria: February 3, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 3, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Blood pressure; Oxidative status
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Calcium; Calcium, Dietary
• Other Study ID Numbers: calcium and vitamin D in HW

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No