Hypertension, Postmenopausal Disorder
Conditions
Keywords
Blood pressure, Oxidative status
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.
Interventions
DIETARY_SUPPLEMENTCalcium Arm
1000 mg Calcium tablet / day will be added to the usual treatment for each patient for a period of 8 weeks.
DIETARY_SUPPLEMENTVitamin 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.
Sponsors
Yaounde Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
The double-blind model is applied to the study. Only the adjudicator, responsible for the distribution of medication knew the different regimes. Calcium and Vitamin D/Calcium were packaged in boxes of identical appearance and labeled for each participant by name and number of the randomization program. The randomization and packaging of the drugs was done by an investigator who had no clinical involvement.
Intervention model description
This study is a double blind, randomized, controlled parallel clinical trial conducted at the Yaounde central hospital, Cameroon
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in serum concentration of anti-oxidant markers: Ferric reducing antioxidant Power (micromol) | 8 weeks | Change in concentration of anti oxidant marker from baseline to week 8. By spectrophotometer |
Countries
Cameroon
Outcome results
None listed