Vitamin D DeficiencyNCT06338059
Relationship Between Vitamin D and Vitamin B12 Levels and Neuropathic Pain in Lipedema
An observational study of Vitamin D Deficiency and B12 Deficiency Vitamin, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Lipedema is a disease characterized by bilateral abnormal fat deposition in the upper and lower extremities. Pain is a common symptom in lipedema.Vitamin D plays an important role in chronic pain. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Vitamin D Deficiency, B12 Deficiency Vitamin, Lipedema
- What is being tested?
- Vitamin B12 Level
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 1 Jun 2024
- How long will I take part?
- 2 Months
- 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 to 70 years
- Women only
- Adult, Older adult
Study population: lipedema patients
Who may be able to join
- The patients diagnosed byan experienced physical medicine and rehabilitation specialist for the diagnosis of lipedema
Who cannot join
- individuals who did not have 25(OH)D and B12 values in the past 6 months,
- those with a history of gastrectomy or bypass surgery,
- those consuming a vegetarian diet, those with lymphedema or chronic venous insufficiency, endocrine diseases, rheumatic diseases, malignancy, neurological diseases, and musculoskeletaldiseases that can be related to lower extremity neuropathic or nociceptivepain.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between Vitamin D and Vitamin B12 Levels and Neuropathic Pain in Lipedema:Cross Sectional Study
Lipedema is a disease characterized by bilateral abnormal fat deposition in the upper and lower extremities. Pain is a common symptom in lipedema.Vitamin D plays an important role in chronic pain. Vitamin B have analgesic role in some neuropathic pain conditions.This study aimedto evaluate the relationship between vitamin D and vitamin B12 levels and neuropathic pain in lipedema.
Read the detailed description
In this cross sectional study 200 lipedema patients will beincluded. According to painDETECT questionnaire scores of cases with lipedema patients will be divided into two groups;An overall score of > 13 likely or possible neuropathic pain (group 1) and <13 unlikely NP (group 2). Patients' age, gender, comorbid diseases and laboratory values (25 OH vitamin D and vitamin B12 levels) will be recorded.
- Conditions
- Vitamin D Deficiency, B12 Deficiency Vitamin, Lipedema
- Being tested
- Vitamin B12 Level
- Keywords
- Vitamin D, B12 Deficiency Vitamin,Lipedema,Pain
- Medical subject headings
- Vitamin D Deficiency, Vitamin B 12 Deficiency, Lipedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin B12 LevelOther
Also called 25 OH Vitamin D Level
Vitamin B12 Level Laboratory measurement of patient's vitamin B12 level in unit of pg/mL 25 OH Vitamin D Level Laboratory measurement of patient's 25 OH vitamin D level in unit of ng/dl
| Study group | Role | What they receive |
|---|---|---|
| painDETECT questionnaire scores> 13 likely or possible neuropathic pain (group 1) | lipedema patients showing NP symptoms Receives: Other: Vitamin B12 Level | |
| painDETECT questionnaire scores13 unlikely neuropathic pain(group 2) | lipedema patients showing no NP symptoms Receives: Other: Vitamin B12 Level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin B12 Level
Laboratory measurement of patient's vitamin B12 level in unit of pg/mL
Measured: 1 day
25 OH Vitamin D Level
Laboratory measurement of patient's 25 OH vitamin D level in unit of ng/dl
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start1 Mar 2024
- Primary completion1 May 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06338059
- Sponsor's protocol ID
- Gulcanozturkchatipchousein
- Status last verified
- Mar 2024
- First submitted
- 23 Mar 2024
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Poojari A, Dev K, Rabiee A. Lipedema: Insights into Morphology, Pathophysiology, and Challenges. Biomedicines. 2022 Nov 30;10(12):3081. doi: 10.3390/biomedicines10123081.
PubMed 36551837Kiraly SJ, Kiraly MA, Hawe RD, Makhani N. Vitamin D as a neuroactive substance: review. ScientificWorldJournal. 2006 Jan 26;6:125-39. doi: 10.1100/tsw.2006.25.
PubMed 16493517Gharibpoor F, Ghavidel-Parsa B, Sattari N, Bidari A, Nejatifar F, Montazeri A. Effect of vitamin B12 on the symptom severity and psychological profile of fibromyalgia patients; a prospective pre-post study. BMC Rheumatol. 2022 Sep 1;6(1):51. doi: 10.1186/s41927-022-00282-y.
PubMed 36045399Ozturk G, Akpinar P, Silte Karamanlioglu D, Akan Begoglu F, Unlu Ozkan F, Aktas I. Relationship Between 25-Hydroxyvitamin D and Vitamin B12 Levels and Neuropathic Pain in Patients Diagnosed with Lipedema. Lymphat Res Biol. 2025 Jun;23(3):203-211. doi: 10.1089/lrb.2024.0083. Epub 2025 Apr 16.
PubMed 40235450
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Vitamin D and Vitamin B12 Levels and Neuropathic Pain in Lipedema:Cross Sectional Study
- ClinicalTrials.gov ID
- NCT06338059
- Acronym / sponsor ID
- Gulcanozturkchatipchousein
- Conditions
- Vitamin D Deficiency, B12 Deficiency Vitamin, Lipedema
- Keywords
- Vitamin D, B12 Deficiency Vitamin,Lipedema,Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 29 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.
Lipedema is a disease characterized by bilateral abnormal fat deposition in the upper and lower extremities. Pain is a common symptom in lipedema.Vitamin D plays an important role in chronic pain. Vitamin B have analgesic role in some neuropathic pain conditions.This study aimedto evaluate the relationship between vitamin D and vitamin B12 levels and neuropathic pain in lipedema.
Detailed description
In this cross sectional study 200 lipedema patients will beincluded. According to painDETECT questionnaire scores of cases with lipedema patients will be divided into two groups;An overall score of > 13 likely or possible neuropathic pain (group 1) and <13 unlikely NP (group 2). Patients' age, gender, comorbid diseases and laboratory values (25 OH vitamin D and vitamin B12 levels) will be recorded.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| painDETECT questionnaire scores> 13 likely or possible neuropathic pain (group 1) | – | Other: Vitamin B12 Levellipedema patients showing NP symptoms |
| painDETECT questionnaire scores13 unlikely neuropathic pain(group 2) | – | Other: Vitamin B12 Levellipedema patients showing no NP symptoms |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- lipedema patients
Key inclusion criteria (1 listed)
- The patients diagnosed byan experienced physical medicine and rehabilitation specialist for the diagnosis of lipedema
Key exclusion criteria (3 listed)
- individuals who did not have 25(OH)D and B12 values in the past 6 months,
- those with a history of gastrectomy or bypass surgery,
- those consuming a vegetarian diet, those with lymphedema or chronic venous insufficiency, endocrine diseases, rheumatic diseases, malignancy, neurological diseases, and musculoskeletaldiseases that can be related to lower extremity neuropathic or nociceptivepain.
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 B12 LevelAlso: 25 OH Vitamin D LevelVitamin B12 Level Laboratory measurement of patient's vitamin B12 level in unit of pg/mL 25 OH Vitamin D Level Laboratory measurement of patient's 25 OH vitamin D level in unit of ng/dl | Other | painDETECT questionnaire scores13 unlikely neuropathic pain(group 2), painDETECT questionnaire scores> 13 likely or possible neuropathic pain (group 1) |
Primary outcome
Vitamin B12 Level
Time frame: 1 day
Laboratory measurement of patient's vitamin B12 level in unit of pg/mL
25 OH Vitamin D Level
Time frame: 1 day
Laboratory measurement of patient's 25 OH vitamin D level in unit of ng/dl
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Results publication: PubMed 36551837Poojari A, Dev K, Rabiee A. Lipedema: Insights into Morphology, Pathophysiology, and Challenges. Biomedicines. 2022 Nov 30;10(12):3081. doi: 10.3390/biomedicines10123081.
- Results publication: PubMed 16493517Kiraly SJ, Kiraly MA, Hawe RD, Makhani N. Vitamin D as a neuroactive substance: review. ScientificWorldJournal. 2006 Jan 26;6:125-39. doi: 10.1100/tsw.2006.25.
- Results publication: PubMed 36045399Gharibpoor F, Ghavidel-Parsa B, Sattari N, Bidari A, Nejatifar F, Montazeri A. Effect of vitamin B12 on the symptom severity and psychological profile of fibromyalgia patients; a prospective pre-post study. BMC Rheumatol. 2022 Sep 1;6(1):51. doi: 10.1186/s41927-022-00282-y.
- Derived from this study: PubMed 40235450Ozturk G, Akpinar P, Silte Karamanlioglu D, Akan Begoglu F, Unlu Ozkan F, Aktas I. Relationship Between 25-Hydroxyvitamin D and Vitamin B12 Levels and Neuropathic Pain in Patients Diagnosed with Lipedema. Lymphat Res Biol. 2025 Jun;23(3):203-211. doi: 10.1089/lrb.2024.0083. Epub 2025 Apr 16.
- Individual participant dataSharing planned: Undecided
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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 Vitamin D Deficiency and B12 Deficiency Vitamin, run by Fatih Sultan Mehmet Training and Research Hospital 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 29 Mar 2024. 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?
Results are not available in the source record.
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 B12 Level (time frame: 1 day). 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?
On the ClinicalTrials.gov record for NCT06338059, which also lists 4 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 29 Mar 2024.