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

NCT06338059 | Active Not Recruiting

• 1 other identifier: Gulcanozturkchatipchousein
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vitamin D Deficiency; B12 Deficiency Vitamin; Lipedema

Keywords

Vitamin D, B12 Deficiency Vitamin,Lipedema,Pain

Outcome Measures

Primary Outcomes (2)

• Vitamin B12 Level

  Laboratory measurement of patient's vitamin B12 level in unit of pg/mL

  1 day

• 25 OH Vitamin D Level

  Laboratory measurement of patient's 25 OH vitamin D level in unit of ng/dl

  1 day

Study Arms (2)

painDETECT questionnaire scores> 13 likely or possible neuropathic pain (group 1)

lipedema patients showing NP symptoms

Other: Vitamin B12 Level

painDETECT questionnaire scores13 unlikely neuropathic pain(group 2)

lipedema patients showing no NP symptoms

Other: Vitamin B12 Level

Interventions

Vitamin B12 Level OTHER

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

Also known as: 25 OH Vitamin D Level

painDETECT questionnaire scores13 unlikely neuropathic pain(group 2); painDETECT questionnaire scores> 13 likely or possible neuropathic pain (group 1)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

lipedema patients

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead

Study Sites (1)

Gulcan Ozturk

Istanbul, 34752, Turkey (Türkiye)

Location

Related Publications (3)

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

  PMID: 36551837 RESULT

• 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.

  PMID: 16493517 RESULT

• 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/s41927-022-00282-y.

  PMID: 36045399 RESULT

MeSH Terms

Conditions

Vitamin D Deficiency; Vitamin B 12 Deficiency; Lipedema

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Vitamin B Deficiency; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2024
• First Posted: March 29, 2024
• Study Start: March 1, 2024
• Primary Completion: May 1, 2024
• Study Completion: June 1, 2024
• Last Updated: March 29, 2024

Record last verified: 2024-03

Locations

TU (1)