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NCT Number: NCT04255992

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

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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Key information

Conditions

Hypertension Cardiovascular Diseases Postmenopausal Disorder Vascular Diseases

Age range

30 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Yaounde Central Hospital, Cardiology department

Yaoundé, Cameroon

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in nycthemeral blood pressure profile (mmHg)

    Time frame: 8 weeks

    Change in nycthemeral blood pressure profile from baseline to week 08. By using Arterial Blood Pressure Monitoring.

Secondary outcomes

  1. Change in serum concentration of oxidant marker: malondialdehyde (micromol/l)

    Time frame: 8 weeks

    Change in concentration of oxidant marker from baseline to week 8. By spectrophotometer

Other outcomes

  1. Change in serum concentration of anti-oxidant markers: Ferric reducing antioxidant Power (micromol)

    Time frame: 8 weeks

    Change in concentration of anti oxidant marker from baseline to week 8. By spectrophotometer

Sponsors and collaborators

Lead sponsor

Yaounde Central Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 5, 2020
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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