UMIN-CTR Clinical Trial

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
Email	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
Email	nadiabegum.zhs@gmail.com

Sponsor
Institute	University of Dhaka, Bangladesh University of Dhaka, Bangladesh Institute of Nutrition and Food Science
Institute
Department

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)
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054745