Assesment of Vitamin B6 Level in Patients With Major Depressive Disorder

March 26, 2023 updated by: Omnia Abd El Nasser Badry, Assiut University
Estimation of vitamin B 6 levels in diagnosed major depressive disorder patients and their relation to the severity of the disease

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 considered 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(pyridoxal phosphate) 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 Type

Observational

Enrollment (Anticipated)

94

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

94 participants divided into 47 patients diagnosed with major depressive disorder and 47 of normal population as control.

Description

Inclusion Criteria:

  • All participants must fulfill the following inclusion criteria;

    1. Patients diagnosed newly as major depressive disorder according to DSM-5( Diagnostic and Statistical Manual ) and (APA 2013) .
    2. Aged at least 18 years of both sex .
    3. 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 .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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) .
  • 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 .
major depressive disorder patients
patient diagnosed with major depression 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) .
  • 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assesment of vitamin B6 level in patients with Major Depressive Disorder
Time Frame: baseline
Estimation of vitamin B 6 levels in diagnosed major depressive disorder patients and their relation to the severity of the disease
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2023

Primary Completion (Anticipated)

February 1, 2026

Study Completion (Anticipated)

March 1, 2026

Study Registration Dates

First Submitted

December 5, 2022

First Submitted That Met QC Criteria

December 5, 2022

First Posted (Actual)

December 14, 2022

Study Record Updates

Last Update Posted (Actual)

March 28, 2023

Last Update Submitted That Met QC Criteria

March 26, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • vitamin b6 & depression

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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