Vitamin b6 Level & DepressionNCT05649293
Assesment of Vitamin B6 Level in Patients With Major Depressive Disorder
An observational study of Vitamin b6 Level & Depression, run by Assiut University.
Trial summary
Estimation of vitamin B 6 levels in diagnosed major depressive disorder patients and their relation to the severity of the disease Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vitamin b6 Level & Depression
- What is being tested?
- measure vitamin b6 in serum
- How many people
- 94 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2023to Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 94 participants divided into 47 patients diagnosed with major depressive disorder and 47 of normal population as control.
Who may be able to join
- All participants must fulfill the following inclusion criteria;
- Patients diagnosed newly as major depressive disorder according to DSM-5( Diagnostic and Statistical Manual ) and (APA 2013) .
- Aged at least 18 years of both sex .
- Able to give informed consent .
Who cannot join
- Patients have Comorbidity with other psychiatric disorders .
- Patients have chronic medical conditions , chronic debilitating or nutritional disorders .
- for control , Patients with any psychiatric disorders .
Trial locations and contacts
No sites are listed yet.
About this study
Estimation of vitamin B 6 levels in diagnosed major depressive disorder patients and their relation to the severity of the disease
Read the 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.
- Conditions
- Vitamin b6 Level & Depression
- Being tested
- measure vitamin b6 in serum
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measure vitamin b6 in serumOther
- 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 .
| Study group | Role | What they receive |
|---|---|---|
| major depressive disorder patients | patient diagnosed with major depression for first time Receives: Other: measure vitamin b6 in serum | |
| depression free persons | healthy persons Receives: Other: measure vitamin b6 in serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assesment of vitamin B6 level in patients with Major Depressive Disorder
Estimation of vitamin B 6 levels in diagnosed major depressive disorder patients and their relation to the severity of the disease
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start1 Apr 2023 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Vitamin b6 Level & DepressionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omnia Abd El Nasser Badry, Assiut University
- Investigators
- Ahmed A Abdel Rahman, Prof, Study director, Assiut UniversityRomany H Gabra, dr, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05649293
- Sponsor's protocol ID
- vitamin b6 & depression
- Status last verified
- Mar 2023
- First submitted
- 5 Dec 2022
- Last updated
- 28 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hvas AM, Juul S, Bech P, Nexo E. Vitamin B6 level is associated with symptoms of depression. Psychother Psychosom. 2004 Nov-Dec;73(6):340-3. doi: 10.1159/000080386.
PubMed 15479988Greenberg PE, Fournier AA, Sisitsky T, Pike CT, Kessler RC. The economic burden of adults with major depressive disorder in the United States (2005 and 2010). J Clin Psychiatry. 2015 Feb;76(2):155-62. doi: 10.4088/JCP.14m09298.
PubMed 25742202Coppen A, Bailey J. Enhancement of the antidepressant action of fluoxetine by folic acid: a randomised, placebo controlled trial. J Affect Disord. 2000 Nov;60(2):121-30. doi: 10.1016/s0165-0327(00)00153-1.
PubMed 10967371Eisenberg DM, Davis RB, Ettner SL, Appel S, Wilkey S, Van Rompay M, Kessler RC. Trends in alternative medicine use in the United States, 1990-1997: results of a follow-up national survey. JAMA. 1998 Nov 11;280(18):1569-75. doi: 10.1001/jama.280.18.1569.
PubMed 9820257Arevalo SP, Scott TM, Falcon LM, Tucker KL. Vitamin B-6 and depressive symptomatology, over time, in older Latino adults. Nutr Neurosci. 2019 Sep;22(9):625-636. doi: 10.1080/1028415X.2017.1422904. Epub 2018 Jan 16.
PubMed 29338677Moore K, Hughes CF, Hoey L, Ward M, Cunningham C, Molloy AM, Strain JJ, McCarroll K, Casey MC, Tracey F, Laird E, O'Kane M, McNulty H. B-vitamins in Relation to Depression in Older Adults Over 60 Years of Age: The Trinity Ulster Department of Agriculture (TUDA) Cohort Study. J Am Med Dir Assoc. 2019 May;20(5):551-557.e1. doi: 10.1016/j.jamda.2018.11.031. Epub 2019 Jan 25.
PubMed 30692033
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assesment of Vitamin B6 Level in Patients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT05649293
- Acronym / sponsor ID
- vitamin b6 & depression
- Conditions
- Vitamin b6 Level & Depression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 14 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Estimation of vitamin B 6 levels in diagnosed major depressive disorder patients and their relation to the severity of the disease
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| major depressive disorder patients | – | Other: measure vitamin b6 in serumpatient diagnosed with major depression for first time |
| depression free persons | – | Other: measure vitamin b6 in serumhealthy persons |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 94 participants divided into 47 patients diagnosed with major depressive disorder and 47 of normal population as control.
Key inclusion criteria (4 listed)
- All participants must fulfill the following inclusion criteria;
Key exclusion criteria (3 listed)
- Patients have Comorbidity with other psychiatric disorders .
- Patients have chronic medical conditions , chronic debilitating or nutritional disorders .
- for control , Patients with any psychiatric disorders .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 . | Other | depression free persons, major depressive disorder patients |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Background: PubMed 15479988Hvas AM, Juul S, Bech P, Nexo E. Vitamin B6 level is associated with symptoms of depression. Psychother Psychosom. 2004 Nov-Dec;73(6):340-3. doi: 10.1159/000080386.
- Background: PubMed 25742202Greenberg PE, Fournier AA, Sisitsky T, Pike CT, Kessler RC. The economic burden of adults with major depressive disorder in the United States (2005 and 2010). J Clin Psychiatry. 2015 Feb;76(2):155-62. doi: 10.4088/JCP.14m09298.
- Background: PubMed 10967371Coppen A, Bailey J. Enhancement of the antidepressant action of fluoxetine by folic acid: a randomised, placebo controlled trial. J Affect Disord. 2000 Nov;60(2):121-30. doi: 10.1016/s0165-0327(00)00153-1.
- Background: PubMed 9820257Eisenberg DM, Davis RB, Ettner SL, Appel S, Wilkey S, Van Rompay M, Kessler RC. Trends in alternative medicine use in the United States, 1990-1997: results of a follow-up national survey. JAMA. 1998 Nov 11;280(18):1569-75. doi: 10.1001/jama.280.18.1569.
- Background: PubMed 29338677Arevalo SP, Scott TM, Falcon LM, Tucker KL. Vitamin B-6 and depressive symptomatology, over time, in older Latino adults. Nutr Neurosci. 2019 Sep;22(9):625-636. doi: 10.1080/1028415X.2017.1422904. Epub 2018 Jan 16.
- Background: PubMed 30692033Moore K, Hughes CF, Hoey L, Ward M, Cunningham C, Molloy AM, Strain JJ, McCarroll K, Casey MC, Tracey F, Laird E, O'Kane M, McNulty H. B-vitamins in Relation to Depression in Older Adults Over 60 Years of Age: The Trinity Ulster Department of Agriculture (TUDA) Cohort Study. J Am Med Dir Assoc. 2019 May;20(5):551-557.e1. doi: 10.1016/j.jamda.2018.11.031. Epub 2019 Jan 25.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed A Abdel Rahman, Prof study director
Assiut University
Romany H Gabra, dr study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin b6 Level & Depression, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Omnia A badry, dr (01017772726, omniaelbadry952@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assesment of vitamin B6 level in patients with Major Depressive Disorder (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05649293, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023; AzTrials last refreshed its copy on 8 Nov 2026.