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Effect of Patient Education Program on Vitamin D Levels and Health Beliefs

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Summary

NIH has registered a clinical trial (NCT07535671) evaluating whether a structured patient education program improves health beliefs and medication adherence in patients with Vitamin D deficiency. The 6-month trial will randomize 120 adult hypothyroid female patients with serum Vitamin D below 30 ng/dL to either face-to-face education with brochures and monthly phone follow-ups or standard care. The intervention's effectiveness will be measured using the Medication Possession Ratio and serum 25(OH)D levels.

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What changed

NIH registered a new clinical trial on ClinicalTrials.gov studying whether patient education programs improve adherence to Vitamin D supplementation. The single-blind randomized controlled trial targets adult hypothyroid females with serum Vitamin D below 30 ng/mL, comparing an intervention group receiving face-to-face education, brochures, and monthly calls against a control group receiving standard care. Adherence will be assessed via Medication Possession Ratio at 6 months.

The trial registration does not create direct compliance obligations for most organizations. Healthcare institutions conducting similar research should ensure IRB approvals remain current and consider registering their own trials per FDAAA 801 requirements. Patients participating in such programs may benefit from structured education to improve medication adherence.

Archived snapshot

Apr 18, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

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

N/A NCT07535671 Kind: NA Apr 17, 2026

Abstract

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

Interventions: Educational with vitamin D

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Last updated

Classification

Agency
NIH
Published
April 17th, 2026
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07535671

Who this affects

Applies to
Patients Healthcare providers
Industry sector
6211 Healthcare Providers
Activity scope
Clinical trial registration Patient education Medication adherence
Geographic scope
United States US

Taxonomy

Primary area
Public Health
Operational domain
Clinical Operations
Topics
Pharmaceuticals Healthcare

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