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

NCT04255992 | Completed Phase 4 DMC

• 1 other identifier: calcium and vitamin D in HW
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Conditions

Hypertension; Postmenopausal Disorder

Keywords

Blood pressure; Oxidative status

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  8 weeks

Other Outcomes (1)

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

  8 weeks

Study Arms (2)

Calcium arm

ACTIVE COMPARATOR

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

Vitamin D/Calcium

ACTIVE COMPARATOR

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

Interventions

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.

Calcium arm

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.

Vitamin D/Calcium

Eligibility Criteria

• Age: 30 Years - 85 Years
• Gender Eligibility Details: Postmenopausal hypertensive women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Diabetes mellitus or inflammatory diseases
• Hypercalcemia,
• Side effects affecting life quality of patients (determined by the Data Safety Monitoring Board).
• Withdrawal of consent

Sponsors & Collaborators

• Yaounde Central Hospital: lead

Study Sites (1)

Yaounde Central Hospital, Cardiology department

Yaoundé, Cameroon

Location

MeSH Terms

Conditions

Hypertension

Interventions

S100 Calcium Binding Protein G

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Calbindins; Calcium-Binding Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; S100 Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr, Principal investigator

Model Details: This study is a double blind, randomized, controlled parallel clinical trial conducted at the Yaounde central hospital, Cameroon

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: February 5, 2020
• Study Start: November 1, 2018
• Primary Completion: May 15, 2019
• Study Completion: May 15, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-02

Locations

CA (1)