Those Who Provided Written Informed ConsentNCT07535671
The Effect of a Patient Education Program on Vitamin D Levels and Health Beliefs Regarding Vitamin D Use
A study testing Educational with vitamin D in people with Those Who Provided Written Informed Consent and Female Gender, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Those Who Provided Written Informed Consent, Female Gender, Aged 18 Years and Older
- What is being tested?
- Educational with vitamin D
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female,
- Aged 18 years and older,
- Hypothyroid disease,
- Serum vitamin D level < 30 ng/mL,
- Providing written informed consent to participate in the study.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Those Who Provided Written Informed Consent, Female Gender, Aged 18 Years and Older, Hypothyroidism Disease, Serum Vitamin d < 30 ng/dl
- Being tested
- Educational with vitamin D
- Keywords
- Vitamin D, patient education, randomized controlled trials
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational with vitamin DBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Not described |
| Education group | Active comparator | Not described Receives: Behavioral: Educational with vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum 25(OH)D Levels
Assessment of Vitamin D status through serum laboratory analysis
Measured: Baseline and 3 months
Change in Medication Possession Ratio (MPR)
Adherence measured by MPR. Target is defined as >% 80
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start1 Nov 2025
- Primary completion1 Feb 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Those Who Provided Written Informed ConsentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sena Ustaomer, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07535671
- Sponsor's protocol ID
- 2025/257
- Status last verified
- Aug 2026
- First submitted
- 18 Mar 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Patient Education Program on Vitamin D Levels and Health Beliefs Regarding Vitamin D Use
- ClinicalTrials.gov ID
- NCT07535671
- Acronym / sponsor ID
- 2025/257
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | – |
| Education group | Active comparator | Behavioral: Educational with vitamin D |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female,
- Aged 18 years and older,
- Hypothyroid disease,
- Serum vitamin D level < 30 ng/mL,
- Providing written informed consent to participate in the study.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational with vitamin DThis 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 | Behavioural | Education group |
Primary outcome
Change in Serum 25(OH)D Levels
Time frame: Baseline and 3 months
Assessment of Vitamin D status through serum laboratory analysis
Change in Medication Possession Ratio (MPR)
Time frame: Baseline and 3 months
Adherence measured by MPR. Target is defined as >% 80
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No. 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
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational with vitamin D in people with Those Who Provided Written Informed Consent and Female Gender, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum 25(OH)D Levels (time frame: Baseline and 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.