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

Yaounde Central Hospital

Status and phase: Completed; Phase 4

Conditions: Postmenopausal Disorder; Hypertension

Treatments: Dietary Supplement: Calcium Arm; Dietary Supplement: Vitamin D/Calcium

Study type: Interventional

Funder types: Other

Identifiers

NCT04255992

calcium and vitamin D in HW

Details and patient eligibility

About

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

Full 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.

Enrollment: 22 patients

Sex: Female

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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22 participants in 2 patient groups

Calcium arm

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Calcium Arm

Vitamin D/Calcium

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Vitamin D/Calcium