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

NCT06645041 | Completed DMC

• 1 other identifier: CoM-UoS-308
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

Hypertension; Vitamin D Deficiency

Keywords

Vitamin D supplementation; Hypertensive vitamin D deficient; Effect on serum Irisin; Effects on HRV

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  10 weeks

• Heart rate variability (HRV)

  It includes the time domain in milliseconds-ms and frequency domains

  10 weeks

Secondary Outcomes (2)

• Serum Irisin

  10 weeks

• Serum hydroxycholecalciferol

  10 weeks

Study Arms (2)

Hypertensive Vitamin D deficient individuals receiving placebo capsule

PLACEBO COMPARATOR

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

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

Dietary Supplement: Vitamin D (Cholecalciferol )

Interventions

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.

Hypertensive vitamin D deficient individuals receiving Vitamin D supplements

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.

Hypertensive Vitamin D deficient individuals receiving placebo capsule

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• \. Hypertensive individuals who have heart failure and other cardiac or systemic diseases or with recent cardiovascular events.
• \. Secondary hypertension 3. Hypertensive patients who require medication change during the course of the study.
• \. Individuals on Lipid-lowering agents (e.g. simvastatin). 5. The use of other medications affecting blood pressure is not part of the study protocol.
• \. 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.
• \. 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.
• \. Subject diagnosed with neoplasm, or inflammatory or autoimmune diseases 10. Pregnant or lactating female

Sponsors & Collaborators

• University of Sulaimani: lead

Study Sites (3)

University of Sulaimani, College of Medicine (CoM-UoS)

Sulaymaniyah, Iraq, 46001, Iraq

Location

Ministry of Higher Education and Scientific research, University of Sulaimani, College of Medicine (CoM-UoS)

Sulaymaniyah, Kurdistan Region, 46001, Iraq

Location

Anwar Sheikha Medical City/High quality hospitals

Sulaymaniyah, Iraq

Location

MeSH Terms

Conditions

Hypertension; Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Darya S. Abdulateef, Ph.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 13, 2024
• First Posted: October 16, 2024
• Study Start: November 16, 2024
• Primary Completion: August 13, 2025
• Study Completion: August 13, 2025
• Last Updated: August 15, 2025

Record last verified: 2025-08

Locations

IR (3)