HypertensionPhase 4NCT04255992
Short Term Cardiovascular Effects and Oxidative Status of Calcium and Vitamin D Supplementation of Postmenopausal Hypertensive Blacks Women
A Phase 4 study testing Calcium Arm and Vitamin D/Calcium in people with Hypertension and Postmenopausal Disorder, run by Yaounde Central Hospital at 1 site in Cameroon.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 85 years, women only
- Conditions the study is for
- Hypertension, Postmenopausal Disorder
- What is being tested?
- Calcium Arm and Vitamin D/Calcium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteCameroon
- Study dates
- 1 Nov 2018to 15 May 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Diabetes mellitus or inflammatory diseases
- Hypercalcemia,
- Side effects affecting life quality of patients (determined by the Data Safety Monitoring Board).
- Withdrawal of consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short Term Cardiovascular Effects and Oxidative Status of Calcium and Vitamin D Supplementation of Postmenopausal Hypertensive Blacks Women in Sub Saharan Africa
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
Read the 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.
- Conditions
- Hypertension, Postmenopausal Disorder
- Being tested
- Calcium Arm, Vitamin D/Calcium
- Keywords
- Blood pressure, Oxidative status
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium ArmDietary supplement
1000 mg Calcium tablet / day will be added to the usual treatment for each patient for a period of 8 weeks.
Vitamin D/CalciumDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Vitamin D/Calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in nycthemeral blood pressure profile (mmHg)
Change in nycthemeral blood pressure profile from baseline to week 08. By using Arterial Blood Pressure Monitoring.
Measured: 8 weeks
Secondary outcomes (1)
Change in serum concentration of oxidant marker: malondialdehyde (micromol/l)
Change in concentration of oxidant marker from baseline to week 8. By spectrophotometer
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Nov 2018
- Primary completion15 May 2019
- Study completion15 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a double blind, randomized, controlled parallel clinical trial conducted at the Yaounde central hospital, Cameroon
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yaounde Central Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, CN NGANOU-GNINDJIO, MD, MSc, Yaounde Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04255992
- Sponsor's protocol ID
- calcium and vitamin D in HW
- Status last verified
- Feb 2020
- First submitted
- 3 Feb 2020
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Cardiovascular Effects and Oxidative Status of Calcium and Vitamin D Supplementation of Postmenopausal Hypertensive Blacks Women in Sub Saharan Africa
- ClinicalTrials.gov ID
- NCT04255992
- Acronym / sponsor ID
- calcium and vitamin D in HW
- Conditions
- Hypertension, Postmenopausal Disorder
- Keywords
- Blood pressure, Oxidative status
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Yaounde Central HospitalOther government
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This study is a double blind, randomized, controlled parallel clinical trial conducted at the Yaounde central hospital, Cameroon
| Arm | Type | Receives |
|---|---|---|
| Calcium arm | Active comparator | Dietary 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/Calcium | Active comparator | Dietary 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. |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Diabetes mellitus or inflammatory diseases
- Hypercalcemia,
- Side effects affecting life quality of patients (determined by the Data Safety Monitoring Board).
- Withdrawal of consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium Arm1000 mg Calcium tablet / day will be added to the usual treatment for each patient for a period of 8 weeks. | Dietary supplement | Calcium arm |
| Vitamin D/Calcium1000 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. | Dietary supplement | Vitamin D/Calcium |
Primary outcome
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.
1 secondary outcome
Change in serum concentration of oxidant marker: malondialdehyde (micromol/l)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Calcium Arm and Vitamin D/Calcium in people with Hypertension and Postmenopausal Disorder, run by Yaounde Central Hospital at 1 site in Cameroon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cameroon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in nycthemeral blood pressure profile (mmHg) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.