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

NCT07535671 | Active Not Recruiting

• 1 other identifier: 2025/257
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Those Who Provided Written Informed Consent; Female Gender; Aged 18 Years and Older; Hypothyroidism Disease; Serum Vitamin d < 30 ng/dl

Keywords

Vitamin D; patient education; randomized controlled trials

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Control group

NO INTERVENTION

Education group

ACTIVE COMPARATOR

Behavioral: Educational with vitamin D

Interventions

Educational with vitamin D BEHAVIORAL

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

Education group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Male ,
• Under the age of 18,
• Patients who do not provide written informed consent,
• Serum vitamin D levels \> 30 ng/mL

Sponsors & Collaborators

• Karadeniz Technical University: lead

Study Sites (1)

KTU Faculty of Medicine

Trabzon, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Vitamin D

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: April 17, 2026
• Study Start: November 1, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)