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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Vitamin D Deficiency; Lipedema; B12 Deficiency Vitamin
• Intervention / Treatment: Other: Vitamin B12 Level

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 Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34752
    • Gulcan Ozturk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

lipedema patients

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
painDETECT questionnaire scores> 13 likely or possible neuropathic pain (group 1); lipedema patients showing NP symptoms	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; Other Names: 25 OH Vitamin D Level
painDETECT questionnaire scores13 unlikely neuropathic pain(group 2); lipedema patients showing no NP symptoms	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; Other Names: 25 OH Vitamin D Level

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fatih Sultan Mehmet Training and Research Hospital

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: March 23, 2024
• First Submitted That Met QC Criteria: March 23, 2024
• First Posted (Actual): March 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 23, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Vitamin D, B12 Deficiency Vitamin,Lipedema,Pain
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Nutrition Disorders; Connective Tissue Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Deficiency Diseases; Malnutrition; Vitamin B Deficiency; Neuralgia; Vitamin D Deficiency; Vitamin B 12 Deficiency; Vitamin A Deficiency; Avitaminosis; Lipedema; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Vitamin B Complex; Hematinics; Vitamin D; Vitamins; Vitamin B 12; Hydroxocobalamin
• Other Study ID Numbers: Gulcanozturkchatipchousein

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No