UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048031 |
|---|---|
| Receipt number | R000054745 |
| Scientific Title | Effect of vitamin D supplementation on glucose homeostasis among Type 2 Diabetic patients: A Randomized Clinical Trial |
| Date of disclosure of the study information | 2022/06/25 |
| Last modified on | 2022/06/13 18:49:00 |
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Basic information
Public title
Effect of vitamin D supplementation on glucose homeostasis among Type 2 Diabetic patients: A Randomized Clinical Trial
Acronym
BETA CELL FUNCTION OR INSULIN SECRETION (HOMA B)
The amount of glucose cleared from the blood in response to a dose of insulin. A score of less than 100 defined reduced B cell function.
INSULIN RESISTANCE (HOMA IR)
Defined as a condition when normal amount of insulin in body fails to produce the desired response . A score of greater than or equal to 2.0 defined IR.
INSULIN SENSITIVITY
Insulin sensitivity calculate by using the following formula is IS equal to 1 per IR (Normal is less than 3.0)
VITAMIN D STATUS
Vitamin D status was defined as SUFFICIENT with level of vitamin D greater than 30ng per ml and DEFICIENT with level of serum 25 (OH) vit D less than or equal to 30ng per ml.
Scientific Title
Effect of vitamin D supplementation on glucose homeostasis among Type 2 Diabetic patients: A Randomized Clinical Trial
Scientific Title:Acronym
BETA CELL FUNCTION OR INSULIN SECRETION (HOMA B)
The amount of glucose cleared from the blood in response to a dose of insulin. A score of less than 100 defined reduced B cell function.
INSULIN RESISTANCE (HOMA IR)
Defined as a condition when normal amount of insulin in body fails to produce the desired response . A score of greater than or equal to 2.0 defined IR.
INSULIN SENSITIVITY
Insulin sensitivity calculate by using the following formula is IS equal to 1 per IR (Normal is less than 3.0)
VITAMIN D STATUS
Vitamin D status was defined as SUFFICIENT with level of vitamin D greater than 30ng per ml and DEFICIENT with level of serum 25 (OH) vit D less than or equal to 30ng per ml.
Region
| Asia(except Japan) |
Condition
Condition
Type 2 Diabetic patients
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To examine the effect of vitamin D supplementation on glucose homeostasis among Type 2 Diabetic patients by comparing treatment and control group both at baseline and end line
Basic objectives2
Others
Basic objectives -Others
SPECIFIC OBJECTIVES (FOR BOTH TREATMENT AND CONTROL GROUP)
1. Assessment of the socio-demographic characteristics
2. Assessment of nutritional status with anthropometric parameters.
3. Advising, monitoring and controlling the diabetes diet and physical activity.
4. Analyzing different biochemical profile -
- Vitamin D
- Fasting Blood Glucose (FBG)
- Fasting blood insulin (FBI)
- Derived parameter Homeostatic model assessment (HOMA) for beta-cell function, Insulin sensitivity (IS) and insulin resistance (IR)
- HbA1c (Glycated Haemoglobin A1C)
- Serum calcium
- C-reactive protein (CRP)
- MDA (malondialdehyde) and
- SOD (Superoxide dismutase)
5. To find out the influence of vitamin D on
- Fasting blood Insulin (FBI) level
- Fasting blood glucose (FBG) level
- Glycated hemoglobin (HbA1c or A1c) level
- Stress-marker like Malondialdehyde (MDA) and Super-oxide Dismutase level (SOD)
- Serum Calcium and
- Inflammatory-marker like C-reactive protein (CRP) level
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
HYPOTHESIS - ACCEPTED
1. Vitamin D supplementation for 12 weeks would improve glycemic indices of HbA1c among Type 2 diabetic patients as compared to placebo group
2. Vitamin D supplementation for 12 weeks would improve glycemic indices of fasting blood glucose among Type 2 diabetic patients as compared to placebo group
Key secondary outcomes
HYPOTHESIS - REJECTED
1. Vitamin D supplementation for 12 weeks would improve fasting Plasma Insulin.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine | Food | Behavior,custom |
Interventions/Control_1
Vitamin D Supplementation
Interventions/Control_2
Placebo
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 30 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Type 2 diabetic patients of aged 30 year to 70 year who were in treatment of oral hypoglycemic agent.
2. Agreed to maintain their usual dietary and physical activity habits at the time of intervention.
3. Voluntarily willing to participate in this clinical study.
Key exclusion criteria
1. Below 30 years or above 70 years of age with Type I Diabetes Mellitus on insulin
2. Consuming vitamin D supplements within 3 months before beginning of the study
3. Women patients who were pregnant or breastfeeding
Target sample size
146
Research contact person
Name of lead principal investigator
| 1st name | Nadia |
| Middle name | |
| Last name | Begum |
Organization
University of Dhaka, Bangladesh
Division name
Institute of Nutrition and Food Science
Zip code
1207
Address
Apartment No. 3A, House No. 409, Road No. 5, Adabor, Dhaka, Bangladesh
TEL
+8801712929996
nadiabegum.zhs@gmail.com
Public contact
Name of contact person
| 1st name | Nadia |
| Middle name | |
| Last name | Begum |
Organization
University of Dhaka, Bangladesh
Division name
Institute of Nutrition and Food Science
Zip code
1207
Address
Apartment No. 3A, House No. 409, Road No. 5, Adabor, Dhaka, Bangladesh
TEL
+8801712929996
Homepage URL
nadiabegum.zhs@gmail.com
Sponsor or person
Institute
University of Dhaka, Bangladesh
University of Dhaka, Bangladesh
Institute of Nutrition and Food Science
Institute
Department
Personal name
Funding Source
Organization
Ministry of Science and Technology
Ministry of Science and Technology
Bangabandhu Science and Technology Fellowship Trust
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Bangladeshi
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institute of Nutrition and Food Science, University of Dhaka
Address
Dhaka University Campus, Dhaka-1000
Tel
+88 02 9661920-73 (Ext 8400, 8401)
infs@du.ac.bd
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 06 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 03 | Month | 28 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 02 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 11 | Day |
Last modified on
| 2022 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054745
