Assesment of Vitamin B6 Level in Patients With Major Depressive Disorder

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05649293
Collaborator
(none)
94
36.9

Study Details

Study Description

Brief Summary

Estimation of vitamin B 6 levels in diagnosed major depressive disorder patients and their relation to the severity of the disease

Condition or Disease Intervention/Treatment Phase
  • Other: measure vitamin b6 in serum

Detailed Description

Major depressive disorder (MDD) is a chronic health condition with significant consequences for health care costs, disability, quality of life, medical morbidity, and mortality. The World Health Organization (WHO) has consdered depression as the leading cause of disability, a major contributor to overall global burden of disease . The core symptoms of depression are low mood and loss of interest or enjoyment in usually pleasurable activities. Associated symptoms include disturbances to sleep and appetite, reduced energy and concentration, negative thoughts of guilt or worthlessness and suicidal ideation. The International Statistical Classification of Diseases & Related Health Problems (ICD-10) states that for a diagnosis of depression at least five symptoms need to be present, including at least one of the core symptoms, at an intensity that causes functional impairment and for a minimum duration of 2 weeks.

Vitamin B6 (Pyridoxine) is a water-soluble compound that comprises three different pyridine derivatives, pyridoxine, pyridoxal, and pyridoxamine, of which PLP is the biologically most active form. The coenzyme PLP is an essential cofactor for amino acid decarboxylases involved in the synthesis of neurotransmitters implicated in depression, including dopamine, norepinephrine ,serotonin or 5-hydroxytryptamine (5-HT), and γ-amino butyric acid (GABA). it prevents the accumulation of neurotoxic intermediates produced during tryptophan metabolism, acting as a cofactor in the metabolism of tryptophan through the kynurenine aminotransferase and kynureninase enzymes. Inadequate intake of vitamin B6 has recently been linked to an increased risk of anxiety and depression in a cross-sectional study of over 3,000 individuals.

Study Design

Study Type:
Observational
Anticipated Enrollment :
94 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Assesment of Vitamin B6 Level in Patients With Major Depressive Disorder
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2026
Anticipated Study Completion Date :
Mar 1, 2026

Arms and Interventions

Arm Intervention/Treatment
major depressive disorder patients

patient diagnosed with major deprssion for first time

Other: measure vitamin b6 in serum
Vitamin B6 levels can be determined by using Enzyme- linked Immuno sorbent Assay Kit For vitamin B6 . or Chemiluminescence Immunoassays (CLIA) , by Immulite , according to the availability of the kits Venous blood samples will be taken from each patient. Use a serum separator tube and allow samples to clot for 10-20 minutes at room temperature and then centrifuged for 20 minutes at speed of 2000-3000 rpm (round per minute). Remove supernatant, if precipitation appeared, Centrifuge again. Extract as soon as possible after Samples collection, and should be tested as soon as possible after the extraction. If not, samples must be stored in aliquot at -20°C (≤ 1 month) or -80°C (≤ 2 months) to avoid loss of bioactivity and contamination. Hemolyzed Sample will be avoided , as hemolysis will interfere with the results . Can' t detect the sample which contain NaN3, because NaN3 inhibits HRP active

depression free persons

healthy persons

Other: measure vitamin b6 in serum
Vitamin B6 levels can be determined by using Enzyme- linked Immuno sorbent Assay Kit For vitamin B6 . or Chemiluminescence Immunoassays (CLIA) , by Immulite , according to the availability of the kits Venous blood samples will be taken from each patient. Use a serum separator tube and allow samples to clot for 10-20 minutes at room temperature and then centrifuged for 20 minutes at speed of 2000-3000 rpm (round per minute). Remove supernatant, if precipitation appeared, Centrifuge again. Extract as soon as possible after Samples collection, and should be tested as soon as possible after the extraction. If not, samples must be stored in aliquot at -20°C (≤ 1 month) or -80°C (≤ 2 months) to avoid loss of bioactivity and contamination. Hemolyzed Sample will be avoided , as hemolysis will interfere with the results . Can' t detect the sample which contain NaN3, because NaN3 inhibits HRP active

Outcome Measures

Primary Outcome Measures

  1. Assesment of vitamin B6 level in patients with Major Depressive Disorder [baseline]

    Estimation of vitamin B 6 levels in diagnosed major depressive disorder patients and their relation to the severity of the disease

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • All participants must fulfill the following inclusion criteria;
  1. Patients diagnosed newly as major depressive disorder according to DSM 5 and (APA
  1. .
  1. Aged at least 18 years of both sex .

  2. Able to give informed consent .

Exclusion Criteria:
  1. Patients have Comorbidity with other psychiatric disorders .

  2. Patients have chronic medical conditions , chronic debilitating or nutritional disorders .

  3. for control , Patients with any psychiatric disorders .

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Director: Ahmed A Abdel Rahman, Prof, Assiut University
  • Study Director: Romany H Gabra, dr, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Omnia Abd El Nasser Badry, Assesment of vitamin B6 level in patients with Major Depressive Disorder, Assiut University
ClinicalTrials.gov Identifier:
NCT05649293
Other Study ID Numbers:
  • vitamin b6 & depression
First Posted:
Dec 14, 2022
Last Update Posted:
Dec 14, 2022
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 14, 2022