Vitamin D Supplementation in Patients With Depression
Primary Purpose
Depression
Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
vitamin D supplement
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Depression focused on measuring vitamin D- Depression- Cholecalciferol-
Eligibility Criteria
Inclusion Criteria:
- age: 18 to 60 y
- Having mild to moderate depression
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
- Not willing to continue the study
- Failure to follow the Supplemental Program
Sites / Locations
- National Nutrition and Food Technology Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention
control
Arm Description
vitamin D supplement every other week
Placebo every other week
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
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.
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.
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
significant change (mean±SD) in depression status
Depression status will be measured by using Beck questioner at baseline and 8 weeks after intervention.
Full Information
NCT ID
NCT03766074
First Posted
December 4, 2018
Last Updated
December 11, 2018
Sponsor
Tirang R. Neyestani, Ph.D.
1. Study Identification
Unique Protocol Identification Number
NCT03766074
Brief Title
Vitamin D Supplementation in Patients With Depression
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 6, 2018 (Actual)
Primary Completion Date
April 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Tirang R. Neyestani, Ph.D.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
vitamin D- Depression- Cholecalciferol-
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
vitamin D supplement every other week
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
Placebo every other week
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin D supplement
Intervention Description
The intervention group receives 50000 IU of vitamin D every 2 weeks as vitamin D supplements for 8 weeks, provided monthly.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
significant change (mean±SD) in vitamin D status
Description
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
Secondary Outcome Measure Information:
Title
significant change (mean±SD) in serum concentration of IL-1β and IL-6.
Description
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
Title
significant change (mean±SD) in serum concentration of hs-CRP
Description
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
Title
significant change (mean±SD) in serum concentration of bone biomarker
Description
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
Title
significant change (mean±SD) in platelet serotonin concentration (ng/10^9 platelets)
Description
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
Title
significant change (mean±SD) in serum concentration of oxytocin (µU/mL)
Description
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
Title
significant change (mean±SD) in depression status
Description
Depression status will be measured by using Beck questioner at baseline and 8 weeks after intervention.
Time Frame
baseline and 8 weeks after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age: 18 to 60 y
Having mild to moderate depression
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
Not willing to continue the study
Failure to follow the Supplemental Program
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tirang R. Neyestani, Ph.D
Organizational Affiliation
National Nutrition and Food Technology Research Institute
Official's Role
Study Chair
Facility Information:
Facility Name
National Nutrition and Food Technology Research Institute
City
Tehrān
State/Province
Tehran
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36368945
Citation
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.
Results Reference
derived
Learn more about this trial
Vitamin D Supplementation in Patients With Depression
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