|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
15 February 2016 |
|
Main ID: |
NCT02098980 |
|
Date of registration:
|
20/03/2014 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Nutritional Intervention of Type II Diabetes Mellitus by Vitamin D in Qatar
|
|
Scientific title:
|
Nutritional Intervention of Type II Diabetes Mellitus by Vitamin D in Qatar |
|
Date of first enrolment:
|
May 2014 |
|
Target sample size:
|
200 |
|
Recruitment status: |
Recruiting |
|
URL:
|
https://clinicaltrials.gov/show/NCT02098980 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Qatar
| | | | | | | |
|
Contacts
|
|
Name:
|
Mohamed Al-Thani, Ph.D. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Supreme Council of Health |
|
|
Name:
|
Amin Jayyousi, M.D. |
|
Address:
|
|
|
Telephone:
|
0097455530236 |
|
Email:
|
ajayyousi@hamad.qa |
|
Affiliation:
|
|
|
|
Name:
|
Mohamed Al-Thani, Ph.D. |
|
Address:
|
|
|
Telephone:
|
97444070100 |
|
Email:
|
malthani@sch.gov.qa |
|
Affiliation:
|
|
|
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- male or non-pregnant, non-lactating females, aged 18-75
- volunteered to participate by signing the consent form
- BMI ? 40kg/ m2
- serum 25(OH) vitamin D3 (25(OH)D) concentration ?75nmol/L
- fasting serum glucose <7.0 mmol/L
- HOMA insulin resistance index =1.3
- presence of any ONE OR MORE of the following risk factors for type 2 diabetes:
- high BMI (>23)
- high waist circumference according to IDF ethnic specific values for non-
Caucasian (females >80cm; males >90cm)
- family history of diabetes in first-degree relative (parent or sibling)
- previous history of gestational diabetes
- history of high blood glucose, high triglycerides and/or low HDL cholesterol
Exclusion Criteria:
- fasting serum glucose =7.0mmol/L
- history of renal failure or liver disease
- serum urea or creatinine >1.8 times upper limit of normal (ULN)
- serum aspartate or alanine transaminase (AST,ALT) >1.5 times ULN
- current use of drug or drugs to treat diabetes or which influence glucose metabolism
- medical or surgical event requiring hospitalization within 3 months of randomization
- presence of any condition affecting nutrient absorption
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Insulin Resistance
|
|
Intervention(s)
|
|
Dietary Supplement: Vitamin D
|
|
Primary Outcome(s)
|
|
Insulin Resistance
[Time Frame: 6 months]
|
|
Secondary ID(s)
|
|
Vitamin D and Diabetes
|
|
INDDIQAT Trial
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|