MDDNCT03754712
Effect of Vitamin D Administration Along With SSRIs in Patients With Major Depressive Disorder
A study testing Vitamin D3 in people with MDD, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
Trial summary
Several studies suggested low serum levels of vitamin D have been associated with depression. So, the present study is designed to investigate the effect of vitamin D administration along with SSRIs in patients with MDD. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- MDD
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteBangladesh
- Study dates
- 10 Mar 2018to 28 Feb 2019
- Phase
- Interventional
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients with MDD
- patients with PHQ - 9 score more than 10
- serum vitamin D less than 30 ng/ml
- Serum calcium level 8.5-10.5 mg/dl
Who cannot join
- Patients receiving antidepressant and dietary supplement with in last two months.
- Patients with other psychological disorder ( such as schizophrenia, bipolar affective disorder)
- Patients with parathyroid disease, thyroid disease, liver and kidney disease
- Patients with Diabetes mellitus
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site, 1 recruiting
- Recruiting
BSMMU
Dhaka
Tanzina Afrin, MBBS, 01796372338, Tanzina.afrin800@gmail.com
Sultanul Arifin, MBBS, 01723836535, Sam35th@gmail.com
About this study
Official title: Effect of Vitamin D Administration Along With Selective Serotonin Reuptake Inhibitors (SSRIs) in Patients With Major Depressive Disorder (MDD)
Several studies suggested low serum levels of vitamin D have been associated with depression. So, the present study is designed to investigate the effect of vitamin D administration along with SSRIs in patients with MDD.
Read the detailed description
Depression is a major global health problem. Major depression was ranked as the third leading cause of the global burden of diseases in 2004 and is supposed to occupy the first place by 2030. Major depression is a complex and multifactorial symptom-complex while dysfunctions in various endocrine axes may be independent risk factors in the development of the affective illness. Some recent observations indicate a significant role of vitamin D regarding mood. Vitamin D3 receptors have been found in cerebral cortex, cerebellum, and the limbic system. The active form of vitamin D on the nervous system is associated with modifying the production and release of neurotrophic factors such as nerve growth factor (NGF) which is essential for neuron differentiation, as well as increasing the levels of glial cell line derived neurotrophic factor (GDNF). Vitamin D influence the expression of genes associated GABA-ergic neurotransmission. It also stimulates the expression of tyrosine hydroxylase which is responsible for catecholamines biosynthesis. Lately, positive influences of vitamin D upon patients suffering from MDD have been suggested. This area require further attention and confirmation as little work has been carried out in this field. So, the present study is an attempt to investigate the effect of vitamin D administration along with SSRIs in patients with MDD. The study would be a interventional one to be conducted in the department of Pharmacology and in the department of psychiatry, BSMMU. A total of 90 patients suffering from major depression will be selected according to inclusion and exclusion criteria. The diagnosis of patients suffering from major depression and the selection of SSRIs would be performed by medical officer of the Psychiatry department. After completing necessary formalities including informed consent of the patients, patient's data will be collected to measure baseline complaints of depression. The patients would be divided into two groups: group A and B. Group A would consist of 45 patients who will receive only SSRIs and Group B would consist of 45 patients who will receive SSRIs plus vitamin D (2000IU) orally once daily. Blood sample will be collected to measure serum vitamin D and calcium level at baseline. Then again blood sample will be collected to measure serum vitamin D level after 8 weeks of vitamin D administration. Regularity of medicine intake will be ensured over telephone, pill count, and from the patient's compliance sheet. The study has entails almost no potential risk to the patients. Patients would have every right to quit the experimental procedure any time during the experimentations if they desire each. However, it will be explained to them that the results of the present study may offer better prospects for similar patients in future, and that the present experimentations would carry no potential risk towards their health or their lives provided they strictly follow the instructions conducted to them.
- Conditions
- MDD
- Being tested
- Vitamin D3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
Dietary supplement : Vitamin D3 one tablet of vitamin D3 (2000IU) per day for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Intervention Vitamin D3 along with SSRIs | Active comparator | One tablet of vitamin D3 (2000IU) per day for 8 weeks Receives: Dietary Supplement: Vitamin D3 |
| SSRIs | No intervention | Patients treated with SSRIs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of depression
Changes in severity of depression will be measured through the Patient Health Questionnaire - 9 (PHQ - 9) score at baseline and at 8 weeks
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start10 Mar 2018
- Primary completion10 Jan 2019 (estimated)
- Study completion28 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MDDStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tanzina Afrin, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03754712
- Sponsor's protocol ID
- No. BSMMU /2018/2964
- Status last verified
- Nov 2018
- First submitted
- 25 Nov 2018
- Last updated
- 28 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D Administration Along With Selective Serotonin Reuptake Inhibitors (SSRIs) in Patients With Major Depressive Disorder (MDD)
- ClinicalTrials.gov ID
- NCT03754712
- Acronym / sponsor ID
- No. BSMMU /2018/2964
- Conditions
- MDD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- 10 Mar 2018 (actual)
- Primary completion
- 10 Jan 2019 (estimated)
- Study completion
- 28 Feb 2019 (estimated)
- First posted
- 27 Nov 2018 (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.
Several studies suggested low serum levels of vitamin D have been associated with depression. So, the present study is designed to investigate the effect of vitamin D administration along with SSRIs in patients with MDD.
Detailed description
Depression is a major global health problem. Major depression was ranked as the third leading cause of the global burden of diseases in 2004 and is supposed to occupy the first place by 2030. Major depression is a complex and multifactorial symptom-complex while dysfunctions in various endocrine axes may be independent risk factors in the development of the affective illness. Some recent observations indicate a significant role of vitamin D regarding mood. Vitamin D3 receptors have been found in cerebral cortex, cerebellum, and the limbic system. The active form of vitamin D on the nervous system is associated with modifying the production and release of neurotrophic factors such as nerve growth factor (NGF) which is essential for neuron differentiation, as well as increasing the levels of glial cell line derived neurotrophic factor (GDNF). Vitamin D influence the expression of genes associated GABA-ergic neurotransmission. It also stimulates the expression of tyrosine hydroxylase which is responsible for catecholamines biosynthesis. Lately, positive influences of vitamin D upon patients suffering from MDD have been suggested. This area require further attention and confirmation as little work has been carried out in this field. So, the present study is an attempt to investigate the effect of vitamin D administration along with SSRIs in patients with MDD. The study would be a interventional one to be conducted in the department of Pharmacology and in the department of psychiatry, BSMMU. A total of 90 patients suffering from major depression will be selected according to inclusion and exclusion criteria. The diagnosis of patients suffering from major depression and the selection of SSRIs would be performed by medical officer of the Psychiatry department. After completing necessary formalities including informed consent of the patients, patient's data will be collected to measure baseline complaints of depression. The patients would be divided into two groups: group A and B. Group A would consist of 45 patients who will receive only SSRIs and Group B would consist of 45 patients who will receive SSRIs plus vitamin D (2000IU) orally once daily. Blood sample will be collected to measure serum vitamin D and calcium level at baseline. Then again blood sample will be collected to measure serum vitamin D level after 8 weeks of vitamin D administration. Regularity of medicine intake will be ensured over telephone, pill count, and from the patient's compliance sheet. The study has entails almost no potential risk to the patients. Patients would have every right to quit the experimental procedure any time during the experimentations if they desire each. However, it will be explained to them that the results of the present study may offer better prospects for similar patients in future, and that the present experimentations would carry no potential risk towards their health or their lives provided they strictly follow the instructions conducted to them.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Vitamin D3 along with SSRIs | Active comparator | Dietary Supplement: Vitamin D3One tablet of vitamin D3 (2000IU) per day for 8 weeks |
| SSRIs | No intervention | –Patients treated with SSRIs |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- patients with MDD
- patients with PHQ - 9 score more than 10
- serum vitamin D less than 30 ng/ml
- Serum calcium level 8.5-10.5 mg/dl
Key exclusion criteria (4 listed)
- Patients receiving antidepressant and dietary supplement with in last two months.
- Patients with other psychological disorder ( such as schizophrenia, bipolar affective disorder)
- Patients with parathyroid disease, thyroid disease, liver and kidney disease
- Patients with Diabetes mellitus
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 |
|---|---|---|
| Vitamin D3Dietary supplement : Vitamin D3 one tablet of vitamin D3 (2000IU) per day for 8 weeks | Dietary supplement | Intervention Vitamin D3 along with SSRIs |
Primary outcome
Severity of depression
Time frame: 8 weeks
Changes in severity of depression will be measured through the Patient Health Questionnaire - 9 (PHQ - 9) score at baseline and at 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 in people with MDD, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
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 4 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 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Tanzina Afrin, MBBS (01796372338, Tanzina.afrin800@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of depression (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2018.