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

Phase 4

Completed

• Conditions: Postmenopausal Disorder; Hypertension
• Interventions: Dietary Supplement: Vitamin D/Calcium; Dietary Supplement: Calcium Arm

• Registration Number: NCT04255992
• Lead Sponsor: Yaounde Central Hospital

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

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 Timeline

• Study Start: 2018-11-01
• Primary Completion: 2019-05-15
• Study Completion: 2019-05-15
• Status Verified: 2020-02
• Study First Submitted: 2020-02-03
• Study First Submitted QC: 2020-02-03
• Last Update Submitted: 2020-02-03
• Study First Posted: 2020-02-05
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D/Calcium	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.
Calcium arm	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Yaounde Central Hospital, Cardiology department; 🇨🇲 Yaounde, Cameroon