Vitamin D supplementation for patients with high blood pressure and low vitamin D levels
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.
NA · University of Sulaimani · NCT06645041
This study is testing if taking Vitamin D can help people with high blood pressure who also have low Vitamin D levels feel better and improve their heart health.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 40 Years to 65 Years |
| Sex | All |
| Sponsor | University of Sulaimani (other) |
| Locations | 3 sites (Sulaymaniyah, Kurdistan Region and 2 other locations) |
| Trial ID | NCT06645041 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of Vitamin D supplementation on hypertensive patients who are deficient in Vitamin D. It involves a randomized controlled trial with 160 participants, including 80 hypertensive and 80 normotensive individuals. The hypertensive participants will receive either Vitamin D supplementation or a placebo for 8 weeks, and the study will measure changes in blood pressure, heart rate variability (HRV), and serum levels of Vitamin D and irisin. The goal is to understand the potential role of Vitamin D in managing hypertension and improving cardiovascular health.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with hypertension and Vitamin D deficiency who are managing their condition with medication.
Not a fit: Patients with heart failure, other systemic diseases, or secondary hypertension may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new preventive approach for managing hypertension in patients with Vitamin D deficiency.
How similar studies have performed: While there have been studies on Vitamin D and hypertension, this specific approach focusing on irisin levels and HRV in hypertensive Vitamin D deficient patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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) Exclusion Criteria: * 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
Where this trial is running
Sulaymaniyah, Kurdistan Region and 2 other locations
- Ministry of Higher Education and Scientific research, University of Sulaimani, College of Medicine (CoM-UoS) — Sulaymaniyah, Kurdistan Region, Iraq (RECRUITING)
- University of Sulaimani, College of Medicine (CoM-UoS) — Sulaymaniyah, Iraq (RECRUITING)
- Anwar Sheikha Medical City/High quality hospitals — Sulaymaniyah, Iraq (RECRUITING)
Study contacts
- Principal investigator: Darya S. Abdulateef, Ph.D. — University of Sulaimani/College of Medicine/Branch of Medical Education
- Study coordinator: Darya S. Abdulateef, Ph.D.
- Email: darya.abdulateef@univsul.edu.iq
- Phone: 00964+7701580313
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hypertension, Vitamin D Deficiency, Vitamin D supplementation, Hypertensive vitamin D deficient, Effect on serum Irisin, Effects on HRV