Effect of vitamin D3 on glycemic control, inflammatory markers and 24hr urine protein in patients with insufficiency and deficiency in serum vitamin D level in type 2 diabetes mellitus
The purpose of this study is to evaluate the Effect of vitamin D3 on glycemic control & inflammatory markers & 24hr urine protein in patients with insufficiency and deficiency in serum vitamin D level in type 2 diabetes mellitus. Inclusion criteria include: patients with type 2 diabetes treated with insulin or medication to lower blood sugar levels; have a vitamin D deficiency; insulin and blood sugar-lowering drugs are used on a regular basis; during the last month are not taking calcium and vitamin D supplementation; proteinuria more than 200 mg per 24 hours urine; the serum creatinine less than 2 or GFR above 50. Exclusion criteria: type 1 diabetes; the normal level of vitamin D; not cooperating with the regular use of drugs; serum creatinine greater than 2 or GFR less than 50; D Calcium intake during the last month; unwillingness to continue to participate in the study; calcium in phosphorus above 55; calcium greater than 10, all conditions that affect the ESR, except for the lack of vitamin D. Sixty diabetes type II patients examined by serum biomarker measurement (vitamin D level, fasting blood glucose, HbA1C, 24 –hour urine protein, ESR, CRP). The patients with vitamin D deficiency divided to case and control groups. Case group treated by pearl vitamin D 50000 units, and control group by placebo for a two month. In the end of study, the same biomarkers examined again and compared with before treatment measurements in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015081723656N1
Registration date:2015-08-24, 1394/06/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-08-24, 1394/06/02
Registrant information
Name
Mohsen Kabiri Samani
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 3334 6692
Email address
kabiri.m@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Sciences
Expected recruitment start date
2014-07-16, 1393/04/25
Expected recruitment end date
2014-08-16, 1393/05/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vitamin D3 on glycemic control, inflammatory markers and 24hr urine protein in patients with insufficiency and deficiency in serum vitamin D level in type 2 diabetes mellitus
Public title
Effect of vitamin D3 on glycemic control, inflammatory markers and 24hr urine protein in patients with insufficiency and deficiency in serum vitamin D level in type 2 diabetes mellitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with type 2 diabetes treated with insulin or medication to lower blood sugar levels; have a vitamin D deficiency; insulin and blood sugar-lowering drugs are used on a regular basis; during the last month are not taking calcium and vitamin D supplementation; proteinuria more than 200 mg per 24 hours urine; the serum creatinine less than 2 or GFR above 50. Exclusion criteria: type 1 diabetes; the normal level of vitamin D; not cooperating with the regular use of drugs; serum creatinine greater than 2 or GFR less than 50; D Calcium intake during the last month; unwillingness to continue to participate in the study; calcium in phosphorus above 55; calcium greater than 10, all conditions that affect the ESR, except for the lack of vitamin D.
Age
From 41 years old to 88 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahrekord University of Medical Sciences
Street address
Shahrekord University of Medical Sciences, Rahmatie, Shahrekord
City
Shahrekord
Postal code
Approval date
2014-07-13, 1393/04/22
Ethics committee reference number
92-6-29
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E10, E11,
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
FBS
Timepoint
Before , two and four months after the intervention.
Method of measurement
Lab data
2
Description
Hemoglubin A1c
Timepoint
Before , two and four months after the intervention.
Method of measurement
Lab data
3
Description
ESR
Timepoint
Before , two and four months after the intervention.
Method of measurement
Lab data
4
Description
CRP
Timepoint
Before , two and four months after the intervention.
Method of measurement
Lab data
5
Description
Proteinuria
Timepoint
Before , two and four months after the intervention.
Method of measurement
Lab data
Secondary outcomes
1
Description
Phosphor
Timepoint
Before , two and four months after the intervention.
Method of measurement
Lab data
2
Description
Calcium
Timepoint
Before , two and four months after the intervention.
Method of measurement
Lab data
3
Description
Albumin
Timepoint
Before , two and four months after the intervention.
Method of measurement
Lab data
Intervention groups
1
Description
Intervention group 1: Tablets Pearl vitamin D3 -50000 one unit every week to two months.
Category
Treatment - Drugs
2
Description
Intervention group 2: control group was used placebo.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Imam Ali
Full name of responsible person
Street address
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Dr Ali Momeny
Street address
Shahrekord University of Medical Sciences, Rahmatie, Shahrekord
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord University of Medical Sciences
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
Associate Professor, School of Medicine
Full name of responsible person
Dr Ali Momeny
Position
Shahrekord University of Medical Sciences
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences, Rahmatie, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38 3334 6692
Fax
Email
ali.momeny@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Dr Ali Momeny
Position
Associate Professor, School of Medicine
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences, Rahmatie, Shahrekord
City
shahrekord
Postal code
Phone
+98 983833346692
Fax
Email
ali.momeny@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Dr Mohsen Kabiri Samani
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)