Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000594628
Ethics application status
Not yet submitted
Date submitted
1/05/2014
Date registered
4/06/2014
Date last updated
4/06/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of vitamin D supplement in subjects with type 2 diabetes mellitus
Scientific title
The effect of vitamin D supplement in glycemic control and lipid profile in type 2 diabetes mellitus (DM): an intervention study
Secondary ID [1] 284386 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type2 diabetes mellitus 291555 0
Condition category
Condition code
Metabolic and Endocrine 291937 291937 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each diabetic subject will take 4500 IU/day of vitamin D3 oral drops for two months. During this period, patients will advise to record any compliance or possible side effects of the drug. After 2 months, all physical examination and laboratory measures that had done at first visit will be repeated.
Intervention code [1] 289115 0
Treatment: Drugs
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291842 0
25(OH) vitamin D level will be evaluated by serum assay.
Timepoint [1] 291842 0
Two months after completing taking of 4500 IU/ day of vitamin D oral drops.
Primary outcome [2] 292278 0
Fasting blood glucose will be evaluated by serum assay.
Timepoint [2] 292278 0
Two months after completing taking of 4500 IU/ day of vitamin D oral drops.
Primary outcome [3] 292279 0
Lipid profile will be evaluated by serum assay.
Timepoint [3] 292279 0
Two months after completing taking of 4500 IU/ day of vitamin D oral drops.
Secondary outcome [1] 308079 0
nil
Timepoint [1] 308079 0
nil

Eligibility
Key inclusion criteria
Adult subjects with type 2 diabetes mellitus
Minimum age
40 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
We should exclude any subjects with hepatic, renal malignancy, bone disease, gall bladder disease, and gastrointestinal disease, history of anticonvulsants, calcium, or vitamin D intake for the last 3 months

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2014
Actual
1/03/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 5957 0
Egypt
State/province [1] 5957 0

Funding & Sponsors
Funding source category [1] 289029 0
Self funded/Unfunded
Name [1] 289029 0
Country [1] 289029 0
Primary sponsor type
University
Name
Ain Shams University
Address
12 Khalifa El-Maamon St
Cairo,
Egypt
PO Box 11566
Country
Egypt
Secondary sponsor category [1] 287702 0
None
Name [1] 287702 0
Address [1] 287702 0
Country [1] 287702 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290948 0
European Medicines Agency
Ethics committee address [1] 290948 0
7 Westferry Circus, Canary Wharf, London E14 4HB
Ethics committee country [1] 290948 0
United Kingdom
Date submitted for ethics approval [1] 290948 0
01/04/2014
Approval date [1] 290948 0
Ethics approval number [1] 290948 0
2014-002258-38

Summary
Brief summary
Vitamin D supplement may help in glycemic control and lipid profile in subjects with diabetes mellitus (DM). Our subjects will take 4500 IU/ day of vitamin D tables for two months. Physical examination and some laboratory measures will be formed before and after vitamin D supplement. The laboratory measures are fasting blood glucose, glycated hemoglobin, lipid profile. We will compare these measures to explore the effect of vitamin D in those with diabetes mellitus.
Trial website
Trial related presentations / publications
Public notes
I think that there is no problem in recruiting the participants prior obtaining ethical approval because in this trial vitamin D is safe and approved for marketing. So, no harmful effect will be exist on our selected subjects till ethical approval. Beside this, our trail is open study not blinded and our selected cases will be informed before supplement with informed consent.
Attachments [1] 56 56 0 0
/AnzctrAttachments/366105-2014-002258-38 3rd Country 20140526 Form.pdf

Contacts
Principal investigator
Name 47478 0
Dr Magda Mohamad
Address 47478 0
Ain Shams University
12 Khalifa El-Maamon St
Cairo
Egypt
PO Box 11566
Country 47478 0
Egypt
Phone 47478 0
+201010938272805
Fax 47478 0
Email 47478 0
[email protected]
Contact person for public queries
Name 47479 0
Dr Magda Mohamad
Address 47479 0
Ain Shams University
12 Khalifa El-Maamon St
Cairo
Egypt
PO Box 11566
Country 47479 0
Egypt
Phone 47479 0
+2010938272805
Fax 47479 0
Email 47479 0
[email protected]
Contact person for scientific queries
Name 47480 0
Dr Magda Mohamad
Address 47480 0
Ain Shams University
12 Khalifa El-Maamon St
Cairo
Egypt
PO Box 11566
Country 47480 0
Egypt
Phone 47480 0
+2010938272805
Fax 47480 0
Email 47480 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe Effect of Vitamin D Supplementation on Glycemic Control and Lipid Profile in Patients with Type 2 Diabetes Mellitus.2016https://dx.doi.org/10.1080/07315724.2015.1026427
N.B. These documents automatically identified may not have been verified by the study sponsor.