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

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 6-month mark to compare the effectiveness of the intervention against the control group.

Study Overview

• Status: Active, not recruiting
• Conditions: Those Who Provided Written Informed Consent; Female Gender; Aged 18 Years and Older; Hypothyroidism Disease; Serum Vitamin d < 30 ng/dl
• Intervention / Treatment: Behavioral: Educational with vitamin D

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Trabzon, Turkey (Türkiye)
    • KTU Faculty of Medicine

Participation Criteria

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

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	Assessment of Vitamin D status through serum laboratory analysis	Baseline and 3 months
Change in Medication Possession Ratio (MPR)	Adherence measured by MPR. Target is defined as >% 80	Baseline and 3 months

Collaborators and Investigators

• Sponsor: Karadeniz Technical University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2025
• Primary Completion (Actual): February 1, 2026
• Study Completion (Estimated): 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): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Vitamin D; patient education; randomized controlled trials
• Additional Relevant MeSH Terms: Polycyclic Compounds; Steroids; Fused-Ring Compounds; Secosteroids; Vitamin D
• 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