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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Tanzina Afrin, MBBS contact

01796372338

Tanzina.afrin800@gmail.com

Sultanul Arifin, MBBS contact

01723836535

Sam35th@gmail.com

Bangladesh1 site, 1 recruiting
  • BSMMU

    Dhaka

    Tanzina Afrin, MBBS, 01796372338, Tanzina.afrin800@gmail.com

    Sultanul Arifin, MBBS, 01723836535, Sam35th@gmail.com

    Recruiting

Other trials in Bangladesh

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 groups in NCT03754712
Study groupRoleWhat they receive
Intervention Vitamin D3 along with SSRIsActive comparatorOne tablet of vitamin D3 (2000IU) per day for 8 weeks
Receives: Dietary Supplement: Vitamin D3
SSRIsNo interventionPatients treated with SSRIs

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted27 Nov 2018
  2. Study start10 Mar 2018
  3. Primary completion10 Jan 2019 (estimated)
  4. Study completion28 Feb 2019 (estimated)

Resources

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)
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

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.

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