The Effect of a Patient Education Program on Vitamin D Levels and Health Beliefs Regarding Vitamin D Use

August 13, 2026 updated by: Sena Ustaomer, Karadeniz Technical University

Background and Rationale:

Vitamin D deficiency is a major public health concern. While clinical guidelines provide treatment protocols, medication adherence remains a significant barrier to achieving target serum levels. This study aims to evaluate whether a structured patient education program can improve health beliefs and adherence, ultimately leading to better clinical outcomes.

Study Procedures:

Participants identified with Vitamin D levels <30 ng/mL will be randomized into two groups.

Intervention Group:

Patients will receive a face-to-face education session covering the importance of Vitamin D, correct usage, and potential side effects. They will also receive informative brochures and monthly follow-up phone calls to support adherence.

Control Group:

Patients will receive standard clinical care without additional structured education.Evaluation:Adherence will be monitored using the Medication Possession Ratio (MPR). Serum 25(OH)D levels and Vitamin D Health Belief Scale scores will be reassessed at the 3-month mark to compare the effectiveness of the intervention against the control group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • 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 Locations

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Female,
  • Aged 18 years and older,
  • Hypothyroid disease,
  • Serum vitamin D level < 30 ng/mL,
  • Providing written informed consent to participate in the study.

Exclusion Criteria:

  • Male ,
  • Under the age of 18,
  • Patients who do not provide written informed consent,
  • Serum vitamin D levels > 30 ng/mL
  • Patients who have undergone gastric bypass or bariatric surgery

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Active Comparator: Education group
Behavioral: Educational with vitamin D

This study implements a pharmacist-led patient education program designed to improve treatment adherence and health beliefs in individuals with vitamin D deficiency (25(OH)D < 30 ng/mL). The intervention begins with the collection of sociodemographic data and the administration of the Vitamin D Health Belief Scale to establish a baseline.

The core intervention involves providing the intervention group (n=30) with structured oral counseling and written educational materials (patient brochures) regarding the clinical importance and proper usage of vitamin D. In contrast, the control group receives standard care.

Three months post-intervention, follow-up assessments are conducted via telephone to re-evaluate health beliefs and measure treatment adherence using the Medication Possession Ratio (MPR). The primary success criteria are achieving an MPR ≥ 8

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Serum 25(OH)D Levels
Time Frame: Baseline and 3 months
Assessment of Vitamin D status through serum laboratory analysis
Baseline and 3 months
Change in Medication Possession Ratio (MPR)
Time Frame: Baseline and 3 months
Adherence measured by MPR. Target is defined as >% 80
Baseline and 3 months

Collaborators and Investigators

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

Sponsor

Karadeniz Technical University

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)

November 1, 2025

Primary Completion (Actual)

February 1, 2026

Study Completion (Actual)

June 1, 2026

Study Registration Dates

First Submitted

March 18, 2026

First Submitted That Met QC Criteria

April 10, 2026

First Posted (Actual)

April 17, 2026

Study Record Updates

Last Update Posted (Actual)

August 17, 2026

Last Update Submitted That Met QC Criteria

August 13, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/257

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared to ensure the confidentiality and privacy of the participants, in accordance with the institutional ethics committee's guidelines and local data protection regulations. The data collected during this study contains sensitive clinical information belonging to a specific patient population, and the informed consent obtained from the participants did not include permission for the public sharing or secondary use of their individual raw data by third parties

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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