NCT06645041

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Sulaimani · Academic / Other
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hypertension
• Vitamin D Deficiency

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamin D (Cholecalciferol )	The hypertensive patients with vitamin D deficiency will receive a Vitamin D capsule with a dose of 25,000 IU. They will be asked to receive a capsule per week for 8 subsequent weeks and re-visit the hospital two weeks from the final dose.
DIETARY_SUPPLEMENT	Placebo Capsule(s)	The hypertensive patients with vitamin D deficiency will receive a Placebo capsule. They will be asked to receive a capsule per week for 8 subsequent weeks and re-visit the hospital two weeks from the final dose.

Timeline

• Start date: 2024-11-16
• Primary completion: 2025-08-13
• Completion: 2025-08-13
• First posted: 2024-10-16
• Last updated: 2025-08-15

Locations

3 sites across 1 country: Iraq