The Impact of Vitamin D Supplementation in Hypertensive Vitamin D Deficient Patients.

NCT ID: NCT06645041

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-16
• Study Completion Date: 2025-08-13

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.

Conditions

Hypertension; Vitamin D Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Hypertensive Vitamin D deficient individuals receiving placebo capsule

Hypertensive Vitamin D deficient individuals receiving placebo capsules, 1 capsule/week for 8 weeks

Group Type: PLACEBO_COMPARATOR

Placebo Capsule(s)

Intervention Type: DIETARY_SUPPLEMENT

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.

Hypertensive vitamin D deficient individuals receiving Vitamin D supplements

Hypertensive Vitamin D deficient individuals receiving Vitamin D capsules, 25,000 IU, 1 capsule/week for 8 weeks

Group Type: EXPERIMENTAL

Vitamin D (Cholecalciferol )

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sulaimani

OTHER

Sponsor Role: lead

Responsible Party

Darya Saeed Abdulateef

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Darya S. Abdulateef, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Sulaimani/College of Medicine/Branch of Medical Education

Locations

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

Countries

Iraq

Other Identifiers

CoM-UoS-308

Identifier Type: -

Identifier Source: org_study_id