Relationship Between Vitamin D and Vitamin B12 Levels and Neuropathic Pain in Lipedema

Vitamin D Deficiency Clinical Trial

Official title:

Relationship Between Vitamin D and Vitamin B12 Levels and Neuropathic Pain in Lipedema:Cross Sectional Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06338059
• Other study ID #: Gulcanozturkchatipchousein
• Status: Active, not recruiting
• Start date: March 1, 2024
• Est. completion date: June 1, 2024

Study information

• Verified date: March 2024
• Source: Fatih Sultan Mehmet Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: June 1, 2024
• Est. primary completion date: May 1, 2024
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• The patients diagnosed byan experienced physical medicine and rehabilitation specialist for the diagnosis of lipedema

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Avitaminosis
• B12 Deficiency Vitamin
• Lipedema
• Neuralgia
• Vitamin A Deficiency
• Vitamin B 12 Deficiency
• Vitamin D Deficiency

Intervention

Other:
• Vitamin B12 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

Locations

Country	Name	City	State
Turkey	Gulcan Ozturk	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Fatih Sultan Mehmet Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Gharibpoor 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/ — View Citation

Kiraly 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. — View Citation

Poojari A, Dev K, Rabiee A. Lipedema: Insights into Morphology, Pathophysiology, and Challenges. Biomedicines. 2022 Nov 30;10(12):3081. doi: 10.3390/biomedicines10123081. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitamin B12 Level	Laboratory measurement of patient's vitamin B12 level in unit of pg/mL	1 day
Primary	25 OH Vitamin D Level	Laboratory measurement of patient's 25 OH vitamin D level in unit of ng/dl	1 day