Protocol summary
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Study aim
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The aim of this study is to determine the effect of vitamin D supplementation on severity depression and metabolic status among patients with major depressive disorder.
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Design
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Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial.
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Settings and conduct
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Population and sample size: 40 patients with major depressive disorder of eligible and referred to Kargarnejad Hospital to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria: Patients with major depressive according to DSM-IV-TR criteria, aged 18 to 65 years, the least score 15 on Hamilton Depression scoring system. Exclusion criteria: History of coronary infarction, angina pectoris, stroke or renal stone disease Pregnant or lactating women Smokers Liver problems Substance abuse Non-normal creatinine concentrations Taking dietary supplements during the last 2 months.
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Intervention groups
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Intervention: Patients will be assigned to receive either the vitamin D supplements (intervention group: n=20) or placebo (control group: n=20).
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Main outcome variables
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Depression (primary outcome) and metabolic profiles (secondary outcome) will be quantified at study baseline and end-of-trial.
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201412065623N29
Registration date:
2014-12-19, 1393/09/28
Registration timing:
retrospective
Last update:
2019-09-23, 1398/07/01
Update count:
1
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Registration date
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2014-12-19, 1393/09/28
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Kashan University of Medical Sciences
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Expected recruitment start date
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2014-11-01, 1393/08/10
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Expected recruitment end date
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2014-11-04, 1393/08/13
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effects of vitamin D supplementation on insulin resistance and inflammatory factor in patients with depression
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Public title
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Effect of supplementation in treatment of depression
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with major depressive according to DSM-IV-TR criteria
Aged 18 to 65 years
The least score 15 on Hamilton Depression scoring system.
Exclusion criteria:
History of coronary infarction, angina pectoris, stroke or renal stone disease
Pregnant or lactating women
Smokers
Liver problems
Substance abuse
Non-normal creatinine concentrations
Taking dietary supplements during the last 2 months
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take either vitamin D supplements (n=20) or placebo (n=20). Randomization will be done by the use of computer-generated random numbers.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Placebo has been used to achieve masking of participants and investigators. The researchers and patients will be concealed until the final analyses by a trained staff.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2014-11-01, 1393/08/10
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Ethics committee reference number
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4230/1/5/29/p
Health conditions studied
1
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Description of health condition studied
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Depression
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ICD-10 code
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F32
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ICD-10 code description
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Depressive episode
Primary outcomes
1
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Description
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Depression
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Questionnaire
Secondary outcomes
1
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Description
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Fasting plasma glucose
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Enzymatic
2
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Description
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Triglycerides
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Enzymatic
3
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Description
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Total antioxidant capacity
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Spectrophotometry
4
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Description
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Glutathione
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Spectrophotometry
5
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Description
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Cholesterol
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Enzymatic
6
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Description
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Insulin
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Elisa
Intervention groups
1
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Description
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Intervention group: Vitamin D pearl, 50000 IU, weekly, for 8 weeks orally.
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Category
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Treatment - Drugs
2
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Description
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Control group: Placebo pearl, weekly, for 8 weeks orally.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kashan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available