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Vitamin D Supplementation in Patients With Depression

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ClinicalTrials.gov Identifier: NCT03766074
Recruitment Status : Active, not recruiting
First Posted : December 5, 2018
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
Tirang R. Neyestani, Ph.D., National Nutrition and Food Technology Institute

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.

Condition or disease Intervention/treatment Phase
Depression Dietary Supplement: vitamin D supplement Dietary Supplement: Placebo Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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
Actual Study Start Date : May 6, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Arm Intervention/treatment
Experimental: Intervention
vitamin D supplement every other week
Dietary Supplement: vitamin D supplement
The intervention group receives 50000 IU of vitamin D every 2 weeks as vitamin D supplements for 8 weeks, provided monthly.

Placebo Comparator: control
Placebo every other week
Dietary Supplement: Placebo
placebo




Primary Outcome Measures :
  1. significant increase (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


Secondary Outcome Measures :
  1. significant decrease (mean±SD) in serum concentration of IL-1β and IL-6. [ Time Frame: baseline and 8 weeks after intervention ]
    The serum concentration of IL-1β and IL-6 (pg/mL) will be measured at baseline and 8 weeks after intervention.

  2. significant decrease (mean±SD) in serum concentration of hs-CRP [ Time Frame: baseline and 8 weeks after intervention ]
    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.

  3. significant decrease (mean±SD) in serum concentration of bone biomarker [ Time Frame: baseline and 8 weeks after intervention ]
    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.

  4. significant increase (mean±SD) in platelet serotonin concentration (ng/10^9 platelets) [ Time Frame: baseline and 8 weeks after intervention ]
    The platelet serotonin concentrations (ng/10^9 platelets) will be measured at baseline and 8 weeks after intervention. normal range is 154-1086.

  5. significant increase (mean±SD) in serum concentration of oxytocin (µU/mL) [ Time Frame: baseline and 8 weeks after intervention ]
    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

  6. significant improvement (mean±SD) in depression status [ Time Frame: baseline and 8 weeks after intervention ]
    Depression status will be measured by using Beck questioner at baseline and 8 weeks after intervention.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03766074


Locations
Iran, Islamic Republic of
National Nutrition and Food Technology Research Institute
Tehrān, Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Tirang R. Neyestani, Ph.D.
Investigators
Study Chair: Tirang R. Neyestani, Ph.D National Nutrition and Food Technology Research Institute

Responsible Party: Tirang R. Neyestani, Ph.D., Tirang R. Neyestani, Ph.D. Professor, National Nutrition and Food Technology Institute
ClinicalTrials.gov Identifier: NCT03766074     History of Changes
Other Study ID Numbers: 784
First Posted: December 5, 2018    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tirang R. Neyestani, Ph.D., National Nutrition and Food Technology Institute:
vitamin D- Depression- Cholecalciferol-

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents