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

NCT04255992 — Phase 4, Completed, 22 participants, Yaounde Central Hospital

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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

RegistryNCT04255992
StatusCompleted
PhasePhase 4
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment22 (Actual)
SponsorYaounde Central Hospital (Other gov)
ConditionsHypertension, Postmenopausal Disorder
InterventionsCalcium Arm, Vitamin D/Calcium (Dietary supplement)
Datesstart 2018-11-01, primary completion 2019-05-15, completion 2019-05-15, first posted 2020-02-05, last updated 2020-02-05
Locations1 site in Cameroon

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-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

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Calcium armActive comparatorDietary Supplement: Calcium Arm1000 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/CalciumActive comparatorDietary Supplement: Vitamin D/Calcium1000 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.
  • Calcium Arm (Dietary supplement): 1000 mg Calcium tablet / day will be added to the usual treatment for each patient for a period of 8 weeks.
  • Vitamin D/Calcium (Dietary supplement): 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.

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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 outcomes

  • 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

+Eligibility

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

+Locations (1)

FacilityCityCountryStatus
Yaounde Central Hospital, Cardiology departmentYaoundéCameroon

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