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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
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.
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.
University of Sulaimani, College of Medicine (CoM-UoS)
Sulaymaniyah, Iraq, Iraq
Ministry of Higher Education and Scientific research, University of Sulaimani, College of Medicine (CoM-UoS)
Sulaymaniyah, Kurdistan Region, Iraq
Anwar Sheikha Medical City/High quality hospitals
Sulaymaniyah, Iraq
Systolic Blood pressure
This measure will track mean changes in systolic blood pressure in mmHg, before and after 8 weeks of Vitamin D supplementation. The objective is to observe whether there is a significant decrease in systolic blood pressure in hypertensive patients receiving Vitamin D compared to those receiving a placebo.
Time frame: 10 weeks
Diastolic Blood pressure
This measure will assess mean changes in diastolic blood pressure in mmHg, before and after 8 weeks of Vitamin D supplementation. The study aims to determine if there is a significant decrease in diastolic blood pressure in hypertensive patients receiving Vitamin D compared to the placebo group.
Time frame: 10 weeks
Heart rate variability (HRV)
It includes the time domain in milliseconds-ms and frequency domains
Time frame: 10 weeks
Serum Irisin
Evaluate changes in mean serum irisin levels in pg/ml or mcg/ml, before and after Vitamin D supplementation in hypertensive patients. The change in mean serum irisin will be correlated with changes in blood pressure and HRV to understand its potential role in cardiovascular regulation.
Time frame: 10 weeks
Serum hydroxycholecalciferol
Measure mean serum 25-hydroxyvitamin D levels to confirm the efficacy of supplementation. The levels will be correlated with the mean of blood pressure, HRV, and serum irisin to explore the impact of Vitamin D repletion.
Time frame: 10 weeks
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