EndometriosisNCT06289257
Analysis of Vitamin D and VDR Expression in Endometriosis: A Case-Control Study
An observational study of Endometriosis and Vitamin D Deficiency/Insufficiency, run by Khon Kaen University at 1 site in Thailand.
Trial summary
The goal of this cross-sectional prospective matching study is to evaluate whether serum vitamin D levels and vitamin D receptor (VDR) expression are associated with the presence and severity of endometriosis in women of reproductive age. 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
- Endometriosis, Vitamin D Deficiency/Insufficiency, Vitamin D Status
- What is being tested?
- Vitamin D level and Vitamin D receptor
- How many people
- 108 participants
- Where
- 1 siteThailand
- Study dates
- 6 May 2024to 23 Dec 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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
Study population: Thai women, reproductive age
Who may be able to join
- Women diagnosed with ectopic endometriotic tissue:
- Have a scheduled surgery appointment at Sri Nakarin Hospital.
- Are aged 18 years or older.
- Women undergoing examination at the outpatient department of Sri Nakarin Hospital.
- No history of gynecological diseases or previous treatment for gynecological conditions associated with lower abdominal pain, infections, or abdominal masses at present.
- Have undergone a gynecological examination within the past year, or if examined during the current visit, the results were normal.
- Have undergone an ultrasound examination within the past year, or if examined during the current visit, the ultrasound results were normal.
Who cannot join
- Received vitamin D supplements within the past 3 months prior to volunteering.
- History of chronic infectious diseases.
- Previously treated for autoimmune diseases.
- History of polycystic ovarian.
- History of bone disorders or receiving medications affecting bones.
- Irregular menstrual cycles or absence of menstruation for more than 3 months up to 1 year.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Obstetrics and Gynecology, Faculty of Medicine, Khonkaen University
Khon Kaen, Changwat Khon Kaen, 40000
About this study
Official title: Analysis of Vitamin D and VDR Expression in Women With Advanced Endometriosis: A Case-Control Study in Thailand
The goal of this cross-sectional prospective matching study is to evaluate whether serum vitamin D levels and vitamin D receptor (VDR) expression are associated with the presence and severity of endometriosis in women of reproductive age.
The main questions it aims to answer are:
Read more
- Is there a difference in serum 25-hydroxyvitamin D [25(OH)D] levels between women with endometriosis and healthy controls?
- Is there a correlation between serum vitamin D levels and VDR expression in endometriotic tissues?
- Is there an association between vitamin D status and the severity of endometriosis based on the revised American Society for Reproductive Medicine (rASRM) staging?
Researchers will compare participants with endometriosis to matched healthy controls (1:2 ratio).
Participants will:
- Provide blood samples for serum 25(OH)D measurement.
- Undergo surgical tissue sampling (for the endometriosis group) to assess VDR expression using immunohistochemistry staining.
- Complete structured questionnaires regarding sun exposure, lifestyle, and clinical characteristics.
Read the detailed description
This cross-sectional study aims to investigate the association between serum vitamin D levels and endometriosis, and to further explore the expression of vitamin D receptor (VDR) in endometriotic tissues using immunohistochemistry.
The study enrolled reproductive-aged women diagnosed with endometriosis who underwent laparoscopic surgery and compared them with matched healthy controls based on age and BMI.
Serum levels of 25-hydroxyvitamin D [25(OH)D] were measured using a standardized laboratory assay. Endometriotic tissue samples obtained during surgery were analyzed for VDR expression, qualitative-quantified using the H-score method in both stroma and epithelial compartments. Clinical data, including revised American Society for Reproductive Medicine (rASRM) staging, were used to assess disease severity. Additional data were collected via structured interviews covering sun exposure, reproductive history, lifestyle, and hormonal treatment.
Tissue staining and scoring were reviewed by two blinded pathologists to ensure reproducibility. Data entry validation was performed by cross-checking case report forms with original clinical records, and double data entry methods were used to minimize errors.
Sample size was determined based on prior effect size estimates from published literature, aiming to achieve a power of 80% and significance level of 5%. The study population was sufficient to detect a clinically meaningful difference in vitamin D status between cases and controls.
Missing data were managed using complete case analysis and sensitivity checks. For secondary outcomes, subgroup analyses were conducted based on categorized vitamin D levels (normal, insufficiency, deficiency, severe deficiency).
Statistical analysis included:
- Descriptive statistics for demographic and clinical characteristics.
- Conditional logistic regression or non-parametric equivalents for between-group comparisons.
- Logistic regression models to estimate the odds ratios for severe endometriosis by vitamin D status.
- Correlation analyses between serum vitamin D levels, VDR expression (H-scores), and rASRM scores.
All analyses were performed using STATA version 18.5. The findings aim to clarify the potential role of vitamin D and its receptor in endometriosis pathogenesis and to inform future interventional studies and clinical practice.
- Being tested
- Vitamin D level, Vitamin D receptor
- Keywords
- Vitamin D level, Endometriosis, Vitamin D receptor, rASRM, Immunohistochemistry, 25(OH)D
- Medical subject headings
- Endometriosis, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D levelDiagnostic test
Also called Vitamin D status
Vitamin D level in blood
Vitamin D receptorOther
Vitamin D receptor in endometriosis tissue
| Study group | Role | What they receive |
|---|---|---|
| Endometriosis | Women with endometriosis Receives: Diagnostic Test: Vitamin D level; Other: Vitamin D receptor | |
| Control | Healthy women Receives: Diagnostic Test: Vitamin D level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D level
Vitamin D status
Measured: At enrollment
Secondary outcomes (2)
rASRM
Severity of the disease
Measured: Intra operation
Vitamin D receptor
Tissue staining of Vitamin D antibody
Measured: Up to 4 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start6 May 2024
- Primary completion23 Dec 2024
- Study completion23 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (56)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vitet Layanun, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06289257
- Sponsor's protocol ID
- HE661574
- Status last verified
- Jul 2025
- First submitted
- 20 Feb 2024
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Follow the Center for Ethics in Human Research, Khon Kaen University submission.
Publications
Pludowski P, Takacs I, Boyanov M, Belaya Z, Diaconu CC, Mokhort T, Zherdova N, Rasa I, Payer J, Pilz S. Clinical Practice in the Prevention, Diagnosis and Treatment of Vitamin D Deficiency: A Central and Eastern European Expert Consensus Statement. Nutrients. 2022 Apr 2;14(7):1483. doi: 10.3390/nu14071483.
PubMed 35406098Anglesio MS, Papadopoulos N, Ayhan A, Nazeran TM, Noe M, Horlings HM, Lum A, Jones S, Senz J, Seckin T, Ho J, Wu RC, Lac V, Ogawa H, Tessier-Cloutier B, Alhassan R, Wang A, Wang Y, Cohen JD, Wong F, Hasanovic A, Orr N, Zhang M, Popoli M, McMahon W, Wood LD, Mattox A, Allaire C, Segars J, Williams C, Tomasetti C, Boyd N, Kinzler KW, Gilks CB, Diaz L, Wang TL, Vogelstein B, Yong PJ, Huntsman DG, Shih IM. Cancer-Associated Mutations in Endometriosis without Cancer. N Engl J Med. 2017 May 11;376(19):1835-1848. doi: 10.1056/NEJMoa1614814.
PubMed 28489996Sampson JA. Peritoneal endometriosis due to the menstrual dissemination of endometrial tissue into the peritoneal cavity. American Journal of Obstetrics and Gynecology. 1927;14(4):422-69.
Yu K, Huang ZY, Xu XL, Li J, Fu XW, Deng SL. Estrogen Receptor Function: Impact on the Human Endometrium. Front Endocrinol (Lausanne). 2022 Feb 28;13:827724. doi: 10.3389/fendo.2022.827724. eCollection 2022.
PubMed 35295981Agic A, Xu H, Altgassen C, Noack F, Wolfler MM, Diedrich K, Friedrich M, Taylor RN, Hornung D. Relative expression of 1,25-dihydroxyvitamin D3 receptor, vitamin D 1 alpha-hydroxylase, vitamin D 24-hydroxylase, and vitamin D 25-hydroxylase in endometriosis and gynecologic cancers. Reprod Sci. 2007 Jul;14(5):486-97. doi: 10.1177/1933719107304565.
PubMed 17913968Bulun SE. Yen and Jaffe's Reproductive Endocrinology: Physiology, Pathophysiology and Clinical Management, 9th edition. 9 ed: Elsevier; 2023 12/07/2023. 1040 p.
Bulun SE, Yilmaz BD, Sison C, Miyazaki K, Bernardi L, Liu S, Kohlmeier A, Yin P, Milad M, Wei J. Endometriosis. Endocr Rev. 2019 Aug 1;40(4):1048-1079. doi: 10.1210/er.2018-00242.
PubMed 30994890Bulun SE, Yildiz S, Adli M, Chakravarti D, Parker JB, Milad M, Yang L, Chaudhari A, Tsai S, Wei JJ, Yin P. Endometriosis and adenomyosis: shared pathophysiology. Fertil Steril. 2023 May;119(5):746-750. doi: 10.1016/j.fertnstert.2023.03.006. Epub 2023 Mar 15.
PubMed 36925057Suda K, Nakaoka H, Yoshihara K, Ishiguro T, Tamura R, Mori Y, Yamawaki K, Adachi S, Takahashi T, Kase H, Tanaka K, Yamamoto T, Motoyama T, Inoue I, Enomoto T. Clonal Expansion and Diversification of Cancer-Associated Mutations in Endometriosis and Normal Endometrium. Cell Rep. 2018 Aug 14;24(7):1777-1789. doi: 10.1016/j.celrep.2018.07.037.
PubMed 30110635Inoue S, Hirota Y, Ueno T, Fukui Y, Yoshida E, Hayashi T, Kojima S, Takeyama R, Hashimoto T, Kiyono T, Ikemura M, Taguchi A, Tanaka T, Tanaka Y, Sakata S, Takeuchi K, Muraoka A, Osuka S, Saito T, Oda K, Osuga Y, Terao Y, Kawazu M, Mano H. Uterine adenomyosis is an oligoclonal disorder associated with KRAS mutations. Nat Commun. 2019 Dec 19;10(1):5785. doi: 10.1038/s41467-019-13708-y.
PubMed 31857578Lips P. Vitamin D physiology. Prog Biophys Mol Biol. 2006 Sep;92(1):4-8. doi: 10.1016/j.pbiomolbio.2006.02.016. Epub 2006 Feb 28.
PubMed 16563471Wimalawansa SJ. Infections and Autoimmunity-The Immune System and Vitamin D: A Systematic Review. Nutrients. 2023 Sep 2;15(17):3842. doi: 10.3390/nu15173842.
PubMed 37686873Chailurkit LO, Aekplakorn W, Ongphiphadhanakul B. Regional variation and determinants of vitamin D status in sunshine-abundant Thailand. BMC Public Health. 2011 Nov 10;11:853. doi: 10.1186/1471-2458-11-853.
PubMed 22074319Rajatanavin N, Kanokrungsee S, Aekplakorn W. Vitamin D status in Thai dermatologists and working-age Thai population. J Dermatol. 2019 Mar;46(3):206-212. doi: 10.1111/1346-8138.14742. Epub 2018 Dec 28.
PubMed 30592077Jiang Z, Pu R, Li N, Chen C, Li J, Dai W, Wang Y, Hu J, Zhu D, Yu Q, Shi Y, Yang G. High prevalence of vitamin D deficiency in Asia: A systematic review and meta-analysis. Crit Rev Food Sci Nutr. 2023;63(19):3602-3611. doi: 10.1080/10408398.2021.1990850. Epub 2021 Nov 16.
PubMed 34783278
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Vitamin D and VDR Expression in Women With Advanced Endometriosis: A Case-Control Study in Thailand
- ClinicalTrials.gov ID
- NCT06289257
- Acronym / sponsor ID
- HE661574
- Keywords
- Vitamin D level, Endometriosis, Vitamin D receptor, rASRM, Immunohistochemistry, 25(OH)D
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- 6 May 2024 (actual)
- Primary completion
- 23 Dec 2024 (actual)
- Study completion
- 23 Dec 2024 (actual)
- First posted
- 1 Mar 2024 (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.
The goal of this cross-sectional prospective matching study is to evaluate whether serum vitamin D levels and vitamin D receptor (VDR) expression are associated with the presence and severity of endometriosis in women of reproductive age.
The main questions it aims to answer are:
- Is there a difference in serum 25-hydroxyvitamin D [25(OH)D] levels between women with endometriosis and healthy controls?
- Is there a correlation between serum vitamin D levels and VDR expression in endometriotic tissues?
- Is there an association between vitamin D status and the severity of endometriosis based on the revised American Society for Reproductive Medicine (rASRM) staging?
Researchers will compare participants with endometriosis to matched healthy controls (1:2 ratio).
Participants will:
- Provide blood samples for serum 25(OH)D measurement.
- Undergo surgical tissue sampling (for the endometriosis group) to assess VDR expression using immunohistochemistry staining.
- Complete structured questionnaires regarding sun exposure, lifestyle, and clinical characteristics.
Detailed description
This cross-sectional study aims to investigate the association between serum vitamin D levels and endometriosis, and to further explore the expression of vitamin D receptor (VDR) in endometriotic tissues using immunohistochemistry.
The study enrolled reproductive-aged women diagnosed with endometriosis who underwent laparoscopic surgery and compared them with matched healthy controls based on age and BMI.
Serum levels of 25-hydroxyvitamin D [25(OH)D] were measured using a standardized laboratory assay. Endometriotic tissue samples obtained during surgery were analyzed for VDR expression, qualitative-quantified using the H-score method in both stroma and epithelial compartments. Clinical data, including revised American Society for Reproductive Medicine (rASRM) staging, were used to assess disease severity. Additional data were collected via structured interviews covering sun exposure, reproductive history, lifestyle, and hormonal treatment.
Tissue staining and scoring were reviewed by two blinded pathologists to ensure reproducibility. Data entry validation was performed by cross-checking case report forms with original clinical records, and double data entry methods were used to minimize errors.
Sample size was determined based on prior effect size estimates from published literature, aiming to achieve a power of 80% and significance level of 5%. The study population was sufficient to detect a clinically meaningful difference in vitamin D status between cases and controls.
Missing data were managed using complete case analysis and sensitivity checks. For secondary outcomes, subgroup analyses were conducted based on categorized vitamin D levels (normal, insufficiency, deficiency, severe deficiency).
Statistical analysis included:
- Descriptive statistics for demographic and clinical characteristics.
- Conditional logistic regression or non-parametric equivalents for between-group comparisons.
- Logistic regression models to estimate the odds ratios for severe endometriosis by vitamin D status.
- Correlation analyses between serum vitamin D levels, VDR expression (H-scores), and rASRM scores.
All analyses were performed using STATA version 18.5. The findings aim to clarify the potential role of vitamin D and its receptor in endometriosis pathogenesis and to inform future interventional studies and clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endometriosis | – | Diagnostic Test: Vitamin D level, Other: Vitamin D receptorWomen with endometriosis |
| Control | – | Diagnostic Test: Vitamin D levelHealthy women |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Thai women, reproductive age
Key inclusion criteria (7 listed)
- Women diagnosed with ectopic endometriotic tissue:
- Have a scheduled surgery appointment at Sri Nakarin Hospital.
- Are aged 18 years or older.
- Women undergoing examination at the outpatient department of Sri Nakarin Hospital.
- No history of gynecological diseases or previous treatment for gynecological conditions associated with lower abdominal pain, infections, or abdominal masses at present.
Key exclusion criteria (6 listed)
- Received vitamin D supplements within the past 3 months prior to volunteering.
- History of chronic infectious diseases.
- Previously treated for autoimmune diseases.
- History of polycystic ovarian.
- History of bone disorders or receiving medications affecting bones.
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 |
|---|---|---|
| Vitamin D levelAlso: Vitamin D statusVitamin D level in blood | Diagnostic test | Control, Endometriosis |
| Vitamin D receptorVitamin D receptor in endometriosis tissue | Other | Endometriosis |
Primary outcome
Vitamin D level
Time frame: At enrollment
Vitamin D status
2 secondary outcomes
rASRM
Time frame: Intra operation
Vitamin D receptor
Time frame: Up to 4 weeks after surgery
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 4 Jul 2025.
- Background: PubMed 35406098Pludowski P, Takacs I, Boyanov M, Belaya Z, Diaconu CC, Mokhort T, Zherdova N, Rasa I, Payer J, Pilz S. Clinical Practice in the Prevention, Diagnosis and Treatment of Vitamin D Deficiency: A Central and Eastern European Expert Consensus Statement. Nutrients. 2022 Apr 2;14(7):1483. doi: 10.3390/nu14071483.
- Background: PubMed 28489996Anglesio MS, Papadopoulos N, Ayhan A, Nazeran TM, Noe M, Horlings HM, Lum A, Jones S, Senz J, Seckin T, Ho J, Wu RC, Lac V, Ogawa H, Tessier-Cloutier B, Alhassan R, Wang A, Wang Y, Cohen JD, Wong F, Hasanovic A, Orr N, Zhang M, Popoli M, McMahon W, Wood LD, Mattox A, Allaire C, Segars J, Williams C, Tomasetti C, Boyd N, Kinzler KW, Gilks CB, Diaz L, Wang TL, Vogelstein B, Yong PJ, Huntsman DG, Shih IM. Cancer-Associated Mutations in Endometriosis without Cancer. N Engl J Med. 2017 May 11;376(19):1835-1848. doi: 10.1056/NEJMoa1614814.
- BackgroundSampson JA. Peritoneal endometriosis due to the menstrual dissemination of endometrial tissue into the peritoneal cavity. American Journal of Obstetrics and Gynecology. 1927;14(4):422-69.
- Background: PubMed 35295981Yu K, Huang ZY, Xu XL, Li J, Fu XW, Deng SL. Estrogen Receptor Function: Impact on the Human Endometrium. Front Endocrinol (Lausanne). 2022 Feb 28;13:827724. doi: 10.3389/fendo.2022.827724. eCollection 2022.
- Background: PubMed 17913968Agic A, Xu H, Altgassen C, Noack F, Wolfler MM, Diedrich K, Friedrich M, Taylor RN, Hornung D. Relative expression of 1,25-dihydroxyvitamin D3 receptor, vitamin D 1 alpha-hydroxylase, vitamin D 24-hydroxylase, and vitamin D 25-hydroxylase in endometriosis and gynecologic cancers. Reprod Sci. 2007 Jul;14(5):486-97. doi: 10.1177/1933719107304565.
- BackgroundBulun SE. Yen and Jaffe's Reproductive Endocrinology: Physiology, Pathophysiology and Clinical Management, 9th edition. 9 ed: Elsevier; 2023 12/07/2023. 1040 p.
- Background: PubMed 30994890Bulun SE, Yilmaz BD, Sison C, Miyazaki K, Bernardi L, Liu S, Kohlmeier A, Yin P, Milad M, Wei J. Endometriosis. Endocr Rev. 2019 Aug 1;40(4):1048-1079. doi: 10.1210/er.2018-00242.
- Background: PubMed 36925057Bulun SE, Yildiz S, Adli M, Chakravarti D, Parker JB, Milad M, Yang L, Chaudhari A, Tsai S, Wei JJ, Yin P. Endometriosis and adenomyosis: shared pathophysiology. Fertil Steril. 2023 May;119(5):746-750. doi: 10.1016/j.fertnstert.2023.03.006. Epub 2023 Mar 15.
- Background: PubMed 30110635Suda K, Nakaoka H, Yoshihara K, Ishiguro T, Tamura R, Mori Y, Yamawaki K, Adachi S, Takahashi T, Kase H, Tanaka K, Yamamoto T, Motoyama T, Inoue I, Enomoto T. Clonal Expansion and Diversification of Cancer-Associated Mutations in Endometriosis and Normal Endometrium. Cell Rep. 2018 Aug 14;24(7):1777-1789. doi: 10.1016/j.celrep.2018.07.037.
- Background: PubMed 31857578Inoue S, Hirota Y, Ueno T, Fukui Y, Yoshida E, Hayashi T, Kojima S, Takeyama R, Hashimoto T, Kiyono T, Ikemura M, Taguchi A, Tanaka T, Tanaka Y, Sakata S, Takeuchi K, Muraoka A, Osuka S, Saito T, Oda K, Osuga Y, Terao Y, Kawazu M, Mano H. Uterine adenomyosis is an oligoclonal disorder associated with KRAS mutations. Nat Commun. 2019 Dec 19;10(1):5785. doi: 10.1038/s41467-019-13708-y.
- Background: PubMed 16563471Lips P. Vitamin D physiology. Prog Biophys Mol Biol. 2006 Sep;92(1):4-8. doi: 10.1016/j.pbiomolbio.2006.02.016. Epub 2006 Feb 28.
- Background: PubMed 37686873Wimalawansa SJ. Infections and Autoimmunity-The Immune System and Vitamin D: A Systematic Review. Nutrients. 2023 Sep 2;15(17):3842. doi: 10.3390/nu15173842.
- Individual participant dataSharing planned: No. Follow the Center for Ethics in Human Research, Khon Kaen University submission.
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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?
An observational study of Endometriosis and Vitamin D Deficiency/Insufficiency, run by Khon Kaen University at 1 site in Thailand.
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 7 inclusion and 6 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 4 Jul 2025. 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 Thailand. 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?
Vitamin D level (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06289257, which also lists 56 linked publications.
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 4 Jul 2025.