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

August 13, 2025 updated by: Darya Saeed Abdulateef, University of Sulaimani

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Iraq
      • Sulaymaniyah, Iraq, 46001
        • University of Sulaimani, College of Medicine (CoM-UoS)
      • Sulaymaniyah, Iraq
        • Anwar Sheikha Medical City/High quality hospitals
    • Kurdistan region
      • Sulaymaniyah, Kurdistan region, Iraq, 46001
        • Ministry of Higher Education and Scientific research, University of Sulaimani, College of Medicine (CoM-UoS)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Hypertensive Vitamin D deficient individuals receiving placebo capsule
Hypertensive Vitamin D deficient individuals receiving placebo capsules, 1 capsule/week for 8 weeks
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.
Experimental: 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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Systolic Blood pressure
Time Frame: 10 weeks
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.
10 weeks
Diastolic Blood pressure
Time Frame: 10 weeks
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.
10 weeks
Heart rate variability (HRV)
Time Frame: 10 weeks
It includes the time domain in milliseconds-ms and frequency domains
10 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Serum Irisin
Time Frame: 10 weeks
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.
10 weeks
Serum hydroxycholecalciferol
Time Frame: 10 weeks
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.
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sulaimani

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Darya S. Abdulateef, Ph.D., University of Sulaimani/College of Medicine/Branch of Medical Education

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 16, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 13, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 13, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 13, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CoM-UoS-308

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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