Viewing Study NCT06645041



Ignite Creation Date: 2024-10-26 @ 3:43 PM
Last Modification Date: 2024-10-26 @ 3:43 PM
Study NCT ID: NCT06645041
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-10-13

Brief Title: The Impact of Vitamin D Supplementation in Hypertensive Vitamin D Deficient Patients
Sponsor: None
Organization: None

Study Overview

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
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 25000 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None