An interventional study of vitamin D supplement and Placebo in Depression, sponsored by Tirang R. Neyestani, Ph.D.. Status unknown at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-12-13.
Sponsored by Tirang R. Neyestani, Ph.D. · Not applicable, Interventional, and Supportive care
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.
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.
8,582 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's planned enrollment of 60 is below the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →Tirang R. Neyestani, Ph.D. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
vitamin D supplement every other week
Dietary Supplement: vitamin D supplement
Placebo every other week
Dietary Supplement: Placebo
The intervention group receives 50000 IU of vitamin D every 2 weeks as vitamin D supplements for 8 weeks, provided monthly.
placebo
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
Time frame: baseline and 8 weeks after intervention
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: baseline and 8 weeks after intervention
Plan to share: Undecided
Started May 2018 (actual). Primary completion is estimated for Apr 2019, 11 months after the start.
Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 11 months is below that.
Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Vitamin D
Tirang R. Neyestani, Ph.D.