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
Evaluation of vitamin D supplementation effects on serum 25(OH)D, PTH, pro-inflammatory biomarkers and neurotransmitters involved in depression, and depression status in depressive patients
Design
double-blind clinical trial.
Settings and conduct
In this double-blind clinical trial, 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 case group receives 50000 IU of vitamin D every 2weeks as vitamin D supplements for 8 weeks, provided monthly. The control group receives placebo. The drug schedule of both groups will be unchanged according to the prescribing physician. After 8 weeks, blood sample will be collected from each participant and the studied indices will be evaluated. Data will be analyzed by statistical tests.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
having mild to moderate depression
age:18 to 60 y
non-inclusion criteria:
a history of heart infarction
a history of angina
a history of stroke
a history of kidney stones
a history of high blood pressure (systolic blood pressure higher than 174 or diastolic blood pressure higher than 104 mm Hg)
a history of liver disease
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
Intervention groups
Case: Patients who receive vitamin D supplementation.
Control: Patients receiving placebo.
Main outcome variables
serum 25(OH)D concentration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170926036425N1
Registration date:2018-09-17, 1397/06/26
Registration timing:retrospective
Last update:2018-09-17, 1397/06/26
Update count:0
Registration date
2018-09-17, 1397/06/26
Registrant information
Name
Mina Kaviani
Name of organization / entity
National Nutrition and Food Technology Research Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 2236 0658
Email address
m_kaviani@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-04, 1397/01/15
Expected recruitment end date
2018-07-06, 1397/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific 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
Public title
Vitamin D and depression
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
having mild to moderate depression
age: 18 to 60 y
Exclusion criteria:
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
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
Age
From 18 years old to 60 years old
Gender
Both
Phase
0
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, simple randomization method is used. Each person is given a random code when entering the study, and each person enters one of the two groups, depending on the received code.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participants, clinical caregivers, researcher, outcome evaluator, data analyst, and data monitoring safety committee are kept blind and they are completely unaware of how to place specimens in the case or control group and of the consumption of supplement or placebo. Placebos used, apparently, will be quite similar to supplements.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Nutrition and food Technology Research institute, Shahid Beheshti University of Medical Sci
Street address
No. 7,Shahid Hafezi (West Arghavan) Ave., Farahzadi Blvd., Qods (Gharb) Town
City
Tehran
Province
Tehran
Postal code
1981619573
Approval date
2018-02-03, 1396/11/14
Ethics committee reference number
IR.SBMU.nnftri.Rec.1396.185
Health conditions studied
1
Description of health condition studied
depression
ICD-10 code
F32.9
ICD-10 code description
Major depressive disorder, single episode, unspecified
Primary outcomes
1
Description
serum 25(OH)D concentration
Timepoint
baseline and 8 weeks after intervention
Method of measurement
measurement of serum level of 25OHD
Secondary outcomes
1
Description
proinflammatory biomarkers
Timepoint
baseline and 8 weeks after intervention
Method of measurement
measurement of serum hs-CRP, IL-6, IL-1β concentrations
2
Description
bone biomarker
Timepoint
baseline and 8 weeks after intervention
Method of measurement
measurement of serum parathormone concentration
3
Description
some neurotransmitters involved in depression
Timepoint
baseline and 8 weeks after intervention
Method of measurement
measurement of serum oxytocin and platelet serotonin concentrations
4
Description
depression status
Timepoint
baseline and 8 weeks after intervention
Method of measurement
Using Beck questioner
Intervention groups
1
Description
Intervention group: Every two weeks receives 50000 IU vitamin D as vitamin D supplementation for 8 weeks, which is provided on a monthly basis.
Category
Treatment - Other
2
Description
Control group:Every two weeks receives a placebo apparently quite similar to vitamin D supplement, for 8 weeks, which is provided on a monthly basis.