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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04255992
• Other study ID #: calcium and vitamin D in HW
• Status: Completed
• Phase: Phase 4
• Start date: November 1, 2018
• Est. completion date: May 15, 2019

Study information

• Verified date: February 2020
• Source: Yaounde Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 15, 2019
• Est. primary completion date: May 15, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Postmenopausal Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
Cameroon	Yaounde Central Hospital, Cardiology department	Yaounde

Sponsors (1)

Lead Sponsor	Collaborator
Yaounde Central Hospital

Country where clinical trial is conducted

Cameroon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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