Clinical trial NCT06645041: The Impact of Vitamin D Supplementation in Hypertensive Vitamin D Deficient Patients.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Vitamin D Deficiency
Keywords: Vitamin D supplementation
Hypertensive vitamin D deficient
Effect on serum Irisin
Effects on HRV
Lead sponsor: University of Sulaimani
Sponsor class: OTHER
First posted: 2024-10-16
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: In a prospective study conducted on 160 participants, 80 hypertensive and 80 normotensive individuals, assessing correlations between Vitamin D, irisin, blood pressure, and HRV, hypertensive vitamin D deficient participants will be recruited in a randomized controlled trial. In this clinical trial, 60 hypertensive participants with Vitamin D deficiency will receive either Vitamin D supplementation (25,000 IU weekly) or a placebo for 8 weeks (30 participants in each group).

Outcome measures include systolic and diastolic blood pressure, HRV, serum Vitamin D, and serum irisin levels before and after supplementation.

The aim is to explore the potential role of Vitamin D and irisin in regulating blood pressure and improving HRV, potentially offering preventive measures for hypertension management.

Eligibility 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

Primary outcomes:
measure: Systolic Blood pressure
timeFrame: 10 weeks
measure: Diastolic Blood pressure
timeFrame: 10 weeks
measure: Heart rate variability (HRV)
timeFrame: 10 weeks
Secondary outcomes:
measure: Serum Irisin
timeFrame: 10 weeks
measure: Serum hydroxycholecalciferol
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Sulaymaniyah
country: Iraq
facility: Ministry of Higher Education and Scientific research, University of Sulaimani, College of Medicine (CoM-UoS)
state: Kurdistan Region
city: Sulaymaniyah
country: Iraq
facility: University of Sulaimani, College of Medicine (CoM-UoS)
city: Sulaymaniyah
country: Iraq
facility: Anwar Sheikha Medical City/High quality hospitals
Study officials:
affiliation: University of Sulaimani/College of Medicine/Branch of Medical Education
name: Darya S. Abdulateef, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: