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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02112721




Registration number
NCT02112721
Ethics application status
Date submitted
10/04/2014
Date registered
14/04/2014
Date last updated
8/12/2016

Titles & IDs
Public title
Can Vitamin D Supplementation Prevent Type 2 Diabetes?
Scientific title
Can Vitamin D Supplementation Prevent Type 2 Diabetes by Improving Insulin Sensitivity and Secretion in Overweight Humans?
Secondary ID [1] 0 0
1047897
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Vitamin D Group - Each participant will be given an initial stat dose of 2500 µg (100,000 IU) of Ostelin (Reckitt Benckiser). Thereafter, participants will take 100 µg/day (4,000 IU, 4 tablets) Ostelin daily for a period of 16 weeks.

Placebo comparator: Placebo group - Each participant will be given an equivalent number of placebo tablets
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Initial Insulin Sensitivity Measure using Euglycaemic glucose clamp
Timepoint [1] 0 0
Week 1
Primary outcome [2] 0 0
Follow up Insulin Sensitivity Measure using Euglycaemic glucose clamp
Timepoint [2] 0 0
Week 17
Secondary outcome [1] 0 0
Initial measurement of inflammatory markers
Timepoint [1] 0 0
Week 1
Secondary outcome [2] 0 0
Follow Up Measurement of inflammatory markers
Timepoint [2] 0 0
Week 17
Secondary outcome [3] 0 0
Initial Measure of Adiposity (DEXA)
Timepoint [3] 0 0
Week 1
Secondary outcome [4] 0 0
Follow Up Measure of Adiposity (DEXA)
Timepoint [4] 0 0
Week 17
Secondary outcome [5] 0 0
Initial Oral Glucose Tolerance Test - OGTT
Timepoint [5] 0 0
Week 1
Secondary outcome [6] 0 0
Follow Up Oral Glucose Tolerance Test -OGTT
Timepoint [6] 0 0
Week 17
Secondary outcome [7] 0 0
Initial Acute Insulin Secretory Response - Intravenous Glucose Tolerance Test
Timepoint [7] 0 0
Week 1
Secondary outcome [8] 0 0
Follow up Acute Insulin Secretory Response- Intravenous Glucose Tolerance Test
Timepoint [8] 0 0
Week 17

Eligibility
Key inclusion criteria
* Age >18 or <60 years,
* 25(OH)D < 50 nmol/L
* Weight change < 5 kg in last 12 months
* BMI >25kg/m2 but weight <159kg due to DEXA scan restrictions
* Non-diabetic, no allergy, non-smoker, no high alcohol use
* No current intake of medications including vitamin supplements
* No kidney, cardiovascular, haematological, respiratory, gastrointestinal, endocrine or central nervous system disease, as well as no psychiatric disorders, no active cancer within the last five years; no presence of acute inflammation (by history, physical or laboratory examination)
* Not menopausal, pregnanct or lactating
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Age <18 or > 60 years
* 25(OH)D > 50 nmol/L
* Weight change > 5 kg in last 12 months
* Diabetes (diagnosed or oral glucose tolerance test (OGTT), hypercalcaemia, allergy
* Current smoking habit, high alcohol use
* Current intake of medications including vitamin supplements
* Kidney, cardiovascular, haematological, respiratory, gastrointestinal, endocrine or central nervous system disease, as well as psychiatric disorder, active cancer within the last five years; presence of acute inflammation (by history, physical or laboratory examination)
* Menopause, pregnancy or lactation

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2016
Sample size
Target
Accrual to date
Final
55
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Centre for Health Research and Implementation - Melbourne
Recruitment postcode(s) [1] 0 0
3168 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Monash University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Victoria
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Auckland, New Zealand
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The aim of this study is to determine whether vitamin D supplementation in overweight/obese individuals with vitamin D deficiency can improve insulin secretion and/or insulin resistance by decreasing subclinical inflammation.

Results of the present study may help to identify new strategies to prevent type 2 diabetes in high-risk groups (i.e. overweight and obese individuals, and individuals with a strong family history of diabetes).

Hypothesis: That increasing plasma 25(OH)D concentrations in healthy individuals at risk for type 2 diabetes with low vitamin D levels through vitamin D supplementation, will improve insulin sensitivity and also insulin secretion by reducing the underlying sub-clinical chronic inflammation.

Aims: To establish whether 16-week vitamin D supplementation given to healthy individuals with low vitamin D levels will:

1. improve insulin sensitivity (in vivo and tissue) and/or insulin secretory function
2. determine whether this relationship is mediated by a reduced chronic inflammation
Trial website
https://clinicaltrials.gov/study/NCT02112721
Trial related presentations / publications
Mousa A, Naderpoor N, Wilson K, Plebanski M, de Courten MPJ, Scragg R, de Courten B. Vitamin D supplementation increases adipokine concentrations in overweight or obese adults. Eur J Nutr. 2020 Feb;59(1):195-204. doi: 10.1007/s00394-019-01899-5. Epub 2019 Jan 16.
Scott D, Mousa A, Naderpoor N, de Courten MPJ, Scragg R, de Courten B. Vitamin D supplementation improves waist-to-hip ratio and fasting blood glucose in vitamin D deficient, overweight or obese Asians: A pilot secondary analysis of a randomised controlled trial. J Steroid Biochem Mol Biol. 2019 Feb;186:136-141. doi: 10.1016/j.jsbmb.2018.10.006. Epub 2018 Oct 12.
Mousa A, Naderpoor N, de Courten MP, Teede H, Kellow N, Walker K, Scragg R, de Courten B. Vitamin D supplementation has no effect on insulin sensitivity or secretion in vitamin D-deficient, overweight or obese adults: a randomized placebo-controlled trial. Am J Clin Nutr. 2017 Jun;105(6):1372-1381. doi: 10.3945/ajcn.117.152736. Epub 2017 May 10.
de Courten B, Mousa A, Naderpoor N, Teede H, de Courten MP, Scragg R. Vitamin D supplementation for the prevention of type 2 diabetes in overweight adults: study protocol for a randomized controlled trial. Trials. 2015 Aug 7;16:335. doi: 10.1186/s13063-015-0851-6.
Public notes

Contacts
Principal investigator
Name 0 0
Barbora de Courten, PhD, MD
Address 0 0
Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02112721