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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Hypertension, Postmenopausal Disorder

Intervention / Treatment
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* Dietary Supplement: Calcium Arm
* Dietary Supplement: Vitamin D/Calcium


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study is a double blind, randomized, controlled parallel clinical trial conducted at the Yaounde central hospital, Cameroon
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Calcium arm<br>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<br>* 1000 mg Calcium tablet / day will be added to the usual treatment for each patient for a period of 8 weeks.<br>|
| Active Comparator: Vitamin D/Calcium<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood pressure, Oxidative status