NCT06645041Completed
The Impact of Vitamin D Supplementation in Hypertensive Vitamin D Deficient Patients.
The Relationship of Vitamin D and Irisin With Blood Pressure and Heart Rate Variability in Normotensive and Hypertensive Individuals: The Impact of Vitamin D Supplementation in Hypertensive Vitamin D Deficient Patients.
Source: ClinicalTrials.gov · Last updated 15 Aug 2025
Brief summary (registry, in English)
This study will assess the impact of Vitamin D supplementation on hypertensive patients with Vitamin D deficiency, it will also investigate the relationship between serum Vitamin D, irisin levels, blood pressure, and heart rate variability (HRV) in hypertensive and normotensive individuals. It is hypothesized that a decrease in blood pressure and an increase in HRV will be noted in the hypertensive treatment group (subjects on supplemental vitamin D) in comparison to the hypertensive control group (placebo) upon vitamin D supplementation.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 13 Oct 2024
- Start date
- 16 Nov 2024
- Primary completion date
- 13 Aug 2025
- Lead sponsor
- University of Sulaimani
- Diseases
- High blood pressure
- NCT number
- NCT06645041
What you commit to
- Study type: Interventional
- Participants enrolled: 60
- From 16 Nov 2024 to the primary completion date, 13 Aug 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 1\. Hypertensive individuals who have heart failure and other cardiac or systemic diseases or with recent cardiovascular events.
- 2\. Secondary hypertension 3. Hypertensive patients who require medication change during the course of the study.
- 4\. Individuals on Lipid-lowering agents (e.g. simvastatin). 5. The use of other medications affecting blood pressure is not part of the study protocol.
- 6\. Any subjects on regular supplemental vitamin D or receiving multi-vitamins regularly with vitamin D content of more than 880 IU, one month before recruitment.
- 7\. Individuals with a BMI over 35 or less than 18 kg/m2. 8. Subjects with a significant change in lifestyle, for example, exercise, weight change, or on a specific dietary regimen during or in the previous four weeks of the study.
- 9\. Subject diagnosed with neoplasm, or inflammatory or autoimmune diseases 10. Pregnant or lactating female
Who the study is looking for
- Hypertensive: Adult individual diagnosed with hypertension by a specialist (at least two systolic blood pressure readings above 140 mmHg or diastolic blood pressure readings above 90 mmHg, measured by a qualified professional following American Heart Association guidelines) managing hypertension through medication adherence, and regularly attending heart clinic appointments, with no other systemic diseases.
- Control: Healthy adult individuals without hypertension or a history of other systemic diseases who volunteer and participate in the study, which will be recruited from relatives, friends, colleagues or patient accompanies. - (\*Note: The healthy participants were included in the first part of the study before starting the clinical trial)
Age in the registry: 40 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Sulaimani, College of Medicine (CoM-UoS) Coordinator of this site? Confirm its status | Sulaymaniyah | Iraq | Unknown status |
| Ministry of Higher Education and Scientific research, University of Sulaimani, College of Medicine (CoM-UoS) Coordinator of this site? Confirm its status | Sulaymaniyah | Iraq | Unknown status |
| Anwar Sheikha Medical City/High quality hospitals Coordinator of this site? Confirm its status | Sulaymaniyah | Iraq | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.