HypertensionNCT06645041
The Impact of Vitamin D Supplementation in Hypertensive Vitamin D Deficient Patients.
A study testing Vitamin D (Cholecalciferol ) in people with Hypertension and Vitamin D Deficiency, run by University of Sulaimani at 3 sites in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Vitamin D Deficiency
- What is being tested?
- Vitamin D (Cholecalciferol )
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 3 sitesIraq
- Study dates
- 16 Nov 2024to 13 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Iraq3 sites
University of Sulaimani, College of Medicine (CoM-UoS)
Sulaymaniyah, Iraq, 46001
Ministry of Higher Education and Scientific research, University of Sulaimani, College of Medicine (CoM-UoS)
Sulaymaniyah, Kurdistan Region, 46001
Anwar Sheikha Medical City/High quality hospitals
Sulaymaniyah
About this study
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.
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.
Read the 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
- Being tested
- Vitamin D (Cholecalciferol ), Placebo Capsule(s)
- Keywords
- Vitamin D supplementation, Hypertensive vitamin D deficient, Effect on serum Irisin, Effects on HRV
- Medical subject headings
- Hypertension, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D (Cholecalciferol )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.
Placebo Capsule(s)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.
| Study group | Role | What they receive |
|---|---|---|
| Hypertensive Vitamin D deficient individuals receiving placebo capsule | Placebo comparator | Hypertensive Vitamin D deficient individuals receiving placebo capsules, 1 capsule/week for 8 weeks Receives: Dietary Supplement: Placebo Capsule(s) |
| Hypertensive vitamin D deficient individuals receiving Vitamin D supplements | Experimental | Hypertensive Vitamin D deficient individuals receiving Vitamin D capsules, 25,000 IU, 1 capsule/week for 8 weeks Receives: Dietary Supplement: Vitamin D (Cholecalciferol ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 10 weeks
Heart rate variability (HRV)
It includes the time domain in milliseconds-ms and frequency domains
Measured: 10 weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start16 Nov 2024
- Primary completion13 Aug 2025
- Study completion13 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sulaimani
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darya Saeed Abdulateef, University of Sulaimani
- Investigators
- Darya S. Abdulateef, Ph.D., Principal investigator, University of Sulaimani/College of Medicine/Branch of Medical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06645041
- Sponsor's protocol ID
- CoM-UoS-308
- Status last verified
- Aug 2025
- First submitted
- 13 Oct 2024
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06645041
- Acronym / sponsor ID
- CoM-UoS-308
- Conditions
- Hypertension, Vitamin D Deficiency
- Keywords
- Vitamin D supplementation, Hypertensive vitamin D deficient, Effect on serum Irisin, Effects on HRV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of SulaimaniUniversity, hospital or other
- Study start
- 16 Nov 2024 (actual)
- Primary completion
- 13 Aug 2025 (actual)
- Study completion
- 13 Aug 2025 (actual)
- First posted
- 16 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypertensive Vitamin D deficient individuals receiving placebo capsule | Placebo comparator | Dietary Supplement: Placebo Capsule(s)Hypertensive Vitamin D deficient individuals receiving placebo capsules, 1 capsule/week for 8 weeks |
| Hypertensive vitamin D deficient individuals receiving Vitamin D supplements | Experimental | Dietary Supplement: Vitamin D (Cholecalciferol )Hypertensive Vitamin D deficient individuals receiving Vitamin D capsules, 25,000 IU, 1 capsule/week for 8 weeks |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Hypertensive vitamin D deficient individuals receiving Vitamin D supplements |
| 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. | Dietary supplement | Hypertensive Vitamin D deficient individuals receiving placebo capsule |
Primary outcome
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.
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.
Heart rate variability (HRV)
Time frame: 10 weeks
It includes the time domain in milliseconds-ms and frequency domains
2 secondary outcomes
Serum Irisin
Time frame: 10 weeks
Serum hydroxycholecalciferol
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darya S. Abdulateef, Ph.D. principal investigator
University of Sulaimani/College of Medicine/Branch of Medical Education
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D (Cholecalciferol ) in people with Hypertension and Vitamin D Deficiency, run by University of Sulaimani at 3 sites in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Blood pressure (time frame: 10 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.