DepressionNCT03766074

Vitamin D Supplementation in Patients With Depression

A study testing vitamin D supplement in people with Depression, run by Tirang R. Neyestani, Ph.D. at 1 site in Iran.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Search all trials

Trial summary

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Depression
What is being tested?: vitamin D supplement
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteIran
Study dates: 6 May 2018to Sep 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

age: 18 to 60 y
Having mild to moderate depression

Who cannot join

Having a history of heart infarction
Having a history of angina
Having a history of stroke
Having a history of kidney stones
Having a history of high blood pressure (systolic blood pressure higher than 174 or diastolic blood pressure higher than 104 mm Hg)
Having a history of liver disease

Show all 12Show fewer

Having a history of hyperparathyroidism
Pregnancy and/or lactation
Reproductive-aged women (under 50 years old) who are not receiving adequate contraception
Consuming nutritional supplement containing vitamin D from 2 months ago
Not willing to continue the study
Failure to follow the Supplemental Program

Trial locations and contacts

1 site in 1 country.

Iran1 site

National Nutrition and Food Technology Research Institute
Tehrān, Tehran Province

Other trials in Iran

About this study

Official title: Evaluation of Vitamin D Supplementation Effects on Serum 25(OH)D3, PTH, Pro-inflammatory Biomarkers and Neurotransmitters Involved in Depression, and Depression Status in Depressive Patients

Groups (intervention group receives 50000 IU vitamin D and control group receives placebo) through a random allocation. After 8 weeks, blood sample will be collected from each participant. The studied indices (inflammatory (IL-1β, IL-6, hs-CRP), PTH, platelet serotonin, serum oxytocin, serum 25(OH) D, depression status and anthropometry indices) will be evaluated at beginning and end of interventional period.

Read the detailed description

In this double-blind randomized clinical trial, 60 patients aged 18-60y referred to Baharlou hospital with a history of mild to moderate depression diagnosed by a psychiatrist will be presented to the researcher. After receipt of a signed informed consent form, eligible patients will participate. A general demographic questionnaire will be completed by an interviewer. Individuals are randomly divided into intervention and control groups. A 10-ml venous blood sample will be collected from each participant. The intervention group receives 50000 IU of vitamin D every 2 weeks as vitamin D supplements for 8 weeks, provided monthly. The control group receives placebo. The drug schedule of both groups (if any) will be unchanged according to the prescribing physician. After 8 weeks, blood sample will be collected from each participant. The studied indices (inflammatory (IL-1β, IL-6, hs-CRP), PTH, platelet serotonin, serum oxytocin, serum 25(OH) D, depression status, anthropometry indices) will be evaluated at beginning and end of interventional period. Data will be analyzed by statistical tests.

Conditions: Depression
Being tested: vitamin D supplement, Placebo
Keywords: vitamin D- Depression- Cholecalciferol-
Medical subject headings: Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

vitamin D supplementDietary supplement
The intervention group receives 50000 IU of vitamin D every 2 weeks as vitamin D supplements for 8 weeks, provided monthly.
PlaceboDietary supplement
placebo

Study groups in NCT03766074
Study group	Role	What they receive
Intervention	Experimental	vitamin D supplement every other week Receives: Dietary Supplement: vitamin D supplement
control	Placebo comparator	Placebo every other week Receives: Dietary Supplement: Placebo

What is being measured

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

significant change (mean±SD) in vitamin D status
The serum concentration of 25(OH) D (nmol/L) will be measured at baseline and 8 weeks after intervention. normal range is 25-162 nmol/L
Measured: baseline and 8 weeks after intervention

Secondary outcomes (6)

significant change (mean±SD) in serum concentration of IL-1β and IL-6.
The serum concentration of IL-1β and IL-6 (pg/mL) will be measured at baseline and 8 weeks after intervention.
Measured: baseline and 8 weeks after intervention
significant change (mean±SD) in serum concentration of hs-CRP
The serum concentration of hs-CRP (mg/L) will be measured at baseline and 8 weeks after intervention. normal range is 0.3-8.6 mg/L.
Measured: baseline and 8 weeks after intervention
significant change (mean±SD) in serum concentration of bone biomarker
The serum concentration of parathormone (PTH) (pg/mL) will be measured at baseline and 8 weeks after intervention. normal range is 10-65 pg/mL.
Measured: baseline and 8 weeks after intervention
significant change (mean±SD) in platelet serotonin concentration (ng/10^9 platelets)
The platelet serotonin concentrations (ng/10^9 platelets) will be measured at baseline and 8 weeks after intervention. normal range is 154-1086.
Measured: baseline and 8 weeks after intervention
significant change (mean±SD) in serum concentration of oxytocin (µU/mL)
The serum concentrations of oxytocin (µU/mL) will be measured at baseline and 8 weeks after intervention. normal range is : males:1.1-1.9, females (non-pregnant): 1.0-1.8
Measured: baseline and 8 weeks after intervention
significant change (mean±SD) in depression status
Depression status will be measured by using Beck questioner at baseline and 8 weeks after intervention.
Measured: baseline and 8 weeks after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 May 2018Sep 2019

First posted5 Dec 2018
Study start6 May 2018
Primary completionApr 2019 (estimated)
Study completionSep 2019 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DepressionStudies 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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03766074
Sponsor's protocol ID: 784
Status last verified: Dec 2018
First submitted: 4 Dec 2018
Last updated: 13 Dec 2018
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Kaviani M, Nikooyeh B, Etesam F, Behnagh SJ, Kangarani HM, Arefi M, Yaghmaei P, Neyestani TR. Effects of vitamin D supplementation on depression and some selected pro-inflammatory biomarkers: a double-blind randomized clinical trial. BMC Psychiatry. 2022 Nov 11;22(1):694. doi: 10.1186/s12888-022-04305-3.
PubMed 36368945

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
Active, not recruiting
AI Mental Health Tool vs. Psychoeducation Control
Depressive Disorder, Depressive Symptoms
Not yet recruitingObservational study
The Effects of Extreme Prematurity on Parenting
Depression Disorder, Post Traumatic Stress Disorder PTSD
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Recruiting
Restoring Emotional Needs With Exogenous Ketones for Women With Postpartum Depression
Postpartum Depression (PPD)

All Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Vitamin D Supplementation Effects on Serum 25(OH)D3, PTH, Pro-inflammatory Biomarkers and Neurotransmitters Involved in Depression, and Depression Status in Depressive Patients
ClinicalTrials.gov ID: NCT03766074
Acronym / sponsor ID: 784
Conditions: Depression
Keywords: vitamin D- Depression- Cholecalciferol-
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 60 participants (estimated)
Lead sponsor: Tirang R. Neyestani, Ph.D.University, hospital or other
Study start: 6 May 2018 (actual)
Primary completion: Apr 2019 (estimated)
Study completion: Sep 2019 (estimated)
First posted: 5 Dec 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.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Intervention	Experimental	Dietary Supplement: vitamin D supplementvitamin D supplement every other week
control	Placebo comparator	Dietary Supplement: PlaceboPlacebo every other week

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (2 listed)

age: 18 to 60 y
Having mild to moderate depression

Key exclusion criteria (12 listed)

Having a history of heart infarction
Having a history of angina
Having a history of stroke
Having a history of kidney stones
Having a history of high blood pressure (systolic blood pressure higher than 174 or diastolic blood pressure higher than 104 mm Hg)

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 D supplementThe intervention group receives 50000 IU of vitamin D every 2 weeks as vitamin D supplements for 8 weeks, provided monthly.	Dietary supplement	Intervention
Placeboplacebo	Dietary supplement	control

Primary outcome

significant change (mean±SD) in vitamin D status
Time frame: baseline and 8 weeks after intervention
The serum concentration of 25(OH) D (nmol/L) will be measured at baseline and 8 weeks after intervention. normal range is 25-162 nmol/L

6 secondary outcomes

significant change (mean±SD) in serum concentration of IL-1β and IL-6.
Time frame: baseline and 8 weeks after intervention
significant change (mean±SD) in serum concentration of hs-CRP
Time frame: baseline and 8 weeks after intervention
significant change (mean±SD) in serum concentration of bone biomarker
Time frame: baseline and 8 weeks after intervention
significant change (mean±SD) in platelet serotonin concentration (ng/10^9 platelets)
Time frame: baseline and 8 weeks after intervention
significant change (mean±SD) in serum concentration of oxytocin (µU/mL)
Time frame: baseline and 8 weeks after intervention
significant change (mean±SD) in depression status
Time frame: baseline and 8 weeks after intervention

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2018.
Derived from this study: PubMed 36368945Kaviani M, Nikooyeh B, Etesam F, Behnagh SJ, Kangarani HM, Arefi M, Yaghmaei P, Neyestani TR. Effects of vitamin D supplementation on depression and some selected pro-inflammatory biomarkers: a double-blind randomized clinical trial. BMC Psychiatry. 2022 Nov 11;22(1):694. doi: 10.1186/s12888-022-04305-3.
Individual participant dataSharing planned: Undecided

Related trials for Depression

Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
Active, not recruiting
AI Mental Health Tool vs. Psychoeducation Control
Depressive Disorder, Depressive Symptoms
Not yet recruitingObservational study
The Effects of Extreme Prematurity on Parenting
Depression Disorder, Post Traumatic Stress Disorder PTSD
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Recruiting
Restoring Emotional Needs With Exogenous Ketones for Women With Postpartum Depression
Postpartum Depression (PPD)

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.

Tirang R. Neyestani, Ph.D study chair

National Nutrition and Food Technology Research Institute

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 D supplement in people with Depression, run by Tirang R. Neyestani, Ph.D. at 1 site in Iran.

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 2 inclusion and 12 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 13 Dec 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 Iran. 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. Some participants in this study may receive a placebo. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

significant change (mean±SD) in vitamin D status (time frame: baseline and 8 weeks after intervention). 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 NCT03766074, which also lists 1 linked publication.

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 13 Dec 2018.