Clinical trial NCT04255992: Short Term Cardiovascular Effects and Oxidative Status of Calcium and Vitamin D Supplementation of Postmenopausal Hypertensive Blacks Women
Official title: Short Term Cardiovascular Effects and Oxidative Status of Calcium and Vitamin D Supplementation of Postmenopausal Hypertensive Blacks Women in Sub Saharan Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Postmenopausal Disorder
Keywords: Blood pressure
Oxidative status
Lead sponsor: Yaounde Central Hospital
Sponsor class: OTHER_GOV
First posted: 2020-02-05
Enrollment: 22
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a double blind, randomized, controlled parallel clinical trial conducted at the Yaounde central hospital, Cameroon
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in nycthemeral blood pressure profile (mmHg)
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in serum concentration of oxidant marker: malondialdehyde (micromol/l)
timeFrame: 8 weeks
Other outcomes:
measure: Change in serum concentration of anti-oxidant markers: Ferric reducing antioxidant Power (micromol)
timeFrame: 8 weeks
Locations:
city: Yaounde
country: Cameroon
facility: Yaounde Central Hospital, Cardiology department
Study officials:
References: