1. Home
  2. Approved trials
  3. » فارسی

The effect of oral magnesium supplementation on improvement of depression in depressed patients with magnesium deficiency

Protocol summary

Summary
It's a double-blind, controlled study that is done in two stages. The first stage involved 600 depressed patients referred to the clinic of Yazd Khatamolanbiya. To verify serum magnesium levels in depressed persons. For this purpose we will select persons aged 20-60 years and don't suffer from disorders and such as diseases kidney, liver, heart, thyroid, bleeding disorders, and malignancies, degenerative disease and don't take dietary supplements and antidepressants and diuretics in recent 3 months. And didn't happen events include loss of job, divorce, death of close relatives' family members, and they happened to be in the past 3 months. Beck Depression questionnaire will be completed. Then those whose scores were between 18-35 ml of blood have taken and will be analyzed by the central laboratory of Yazd. Then, between them, 60 patients with hypomagnesaemia ( serum magnesium less than 75 / 0 mmol per liter ) will select and with random codes are divided into two groups .the intervention group give 2magnesiu moxide tablets daily for 8 weeks and the control group give 2plasebo tablets for 8 weeks. People who are don't take Over 20% of medication during study or have started taking supplements or change in the type and dose of their medicines may have to be excluded of this study. After 12 weeks of intervention, serum magnesium Beck will be measured in both groups for the extent complementary. After 12 weeks of intervention, serum magnesium will be measured in both groups to assess the effect of a dietary supplement.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013121015744N1
Registration date: 2014-08-15, 1393/05/24
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-08-15, 1393/05/24
Registrant information
Name
Afsane Rajizadeh
Name of organization / entity
Shahid Sadooghi University of Medical Sciences and Health Services in Yazd
Country
Iran (Islamic Republic of)
Phone
+98 913 633 3662
Email address
a.rajizadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Yazd University of Medical Sciences martyr
Expected recruitment start date
2014-01-20, 1392/10/30
Expected recruitment end date
2014-06-21, 1393/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral magnesium supplementation on improvement of depression in depressed patients with magnesium deficiency
Public title
The effect of magnesium supplementation on depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: people aged 20-60 years old and depression is diagnosed by a psychiatrist; not suffering from disorders and diseases of the kidney, liver, heart, thyroid, bleeding disorders and malignancies; non- degenerative disease autoimmune; non- autoimmune degenerative diseases; lack of central nervous system diseases; no history of mental illness; lack of food; lack of consumption of antidepressants and diuretics during the last 3 months pregnant and not lactating and non- events include loss of job; divorce; death of first-degree relatives in the past 3 months and have not participated in other research projects that self -reporting of this information will be recorded. Exclusion criteria: people who are not more than 20 % of the drug; while studying people who start taking a multivitamin and mineral supplement may have changed who have created the drug are.
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 600
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahid Sadooghi University of Medical Sciences and Health Services in Yazd, Iran
Street address
Educational Research Center, Imam Reza, Next to the Governor, Daneshjo BLV
City
Yazd
Postal code
8916189165
Approval date
2013-11-23, 1392/09/02
Ethics committee reference number
17/1/157228/پ

Health conditions studied

1

Description of health condition studied
Depression
ICD-10 code
F32, F33
ICD-10 code description
This block contains disorders in which the fundamental disturbance is a change in affect or mood to depression (with or without associated anxiety) or to elation. The mood change is usually accompanied by a change in the overall level of activity; most of

Primary outcomes

1

Description
Depression
Timepoint
Before the intervention, and three months after intervention
Method of measurement
Beck Depression Inventory

2

Description
Serum magnesium
Timepoint
Three months after the intervention, but intervention
Method of measurement
Serum magnesium test

Secondary outcomes

1

Description
Diarrhea
Timepoint
Monthly
Method of measurement
Ask the patient

Intervention groups

1

Description
The intervention group included 30 depressed patients with hypo magnesiumia will give daily two tablets of magnesium oxide. They will take tablets after breakfast and after dinner for 8 weeks. after 8 weeks again of the Beck depression test to measure depression and the test Serum Magnesium is performed to assess the situation.
Category
Treatment - Drugs

2

Description
The control group nclude of 30 depressed patients with hypo magnesium daily two tablets of placebo in terms of shape and color appearance similar to the magnesium tablet are a number after breakfast and one after dinner for 8 weeks. and after 8 weeks re-testing of the Beck depression test to assess depression and serum magnesium test is performed to measure magnesium status.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Specialty and subspecialty clinics Khatam Anbiya Yazd
Full name of responsible person
Doctor H. Mozaffari Khosravi
Street address
Specialty and subspecialty clinics Khatam Anbiya, opposite the Fire department, Taleghani Avenue, Yazd
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Council (Research and Technology) of Shahid Sadooghi University of Medical Sciences and Hea
Full name of responsible person
Prof. Hassan Mozaffari Khosravi
Street address
Bahonar Square, Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Council (Research and Technology) of Shahid Sadooghi University of Medical Sciences and Hea
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Sadooghi University of Medical Sciences and Health Services in Yazd
Full name of responsible person
Prof. Hassan Mozaffari Khosravi
Position
PhD Nutrition، Research Assistant in Shahid Sadooghi University of Medical Sciences and Health Servi
Other areas of specialty/work
Street address
Bahonar Square, Yazd
City
Yazd
Postal code
Phone
+98 913 153 1467
Fax
Email
mozaffari.kh@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Sadooghi University of Medical Sciences and Health Services in Yazd
Full name of responsible person
Prof. Hassan Mozaffari Khosravi
Position
PhD Nutrition
Other areas of specialty/work
Street address
Bahonar Square, Yazd
City
Yazd
Postal code
Phone
+98 913 633 3662
Fax
Email
mozaffari.kh@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Afsane Rajizadeh
Position
Graduate student in Nutrition and Health Sciences
Other areas of specialty/work
Street address
Integrated student of Imam Reza, Yazd, Iran
City
Yazd
Postal code
Phone
+98 913 633 3662
Fax
Email
a.rajizadeh@gmail.coma.rajizadeh@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...