Short Term Cardiovascular Effects and Oxidative Status of Calcium and Vitamin D Supplementation of Postmenopausal Hypertensive Blacks Women in Sub Saharan Africa
| Registry | NCT04255992 |
|---|---|
| Status | Completed |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 22 (Actual) |
| Sponsor | Yaounde Central Hospital (Other gov) |
| Conditions | Hypertension, Postmenopausal Disorder |
| Interventions | Calcium Arm, Vitamin D/Calcium (Dietary supplement) |
| Dates | start 2018-11-01, primary completion 2019-05-15, completion 2019-05-15, first posted 2020-02-05, last updated 2020-02-05 |
| Locations | 1 site in Cameroon |
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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
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Calcium arm | Active comparator | Dietary Supplement: 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. |
| Vitamin D/Calcium | Active comparator | Dietary Supplement: 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. |
Sex: Female, ages: 30 Years to 85 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Yaounde Central Hospital, Cardiology department | Yaoundé | Cameroon |