The role of vitamin D receptor (VDR) single nucleotide polymorphisms (SNPs ) in efficacy of vitamin D-fortified yogurt drink on metabolic-, inflammatory – and oxidative stress indicators in type 2 diabetic patients
This is a single-blind controlled trial on the possible effects of vitamin D receptor (VDR) polymorphisms on efficacy of vitamin D intake in the patients with type 2 diabetes mellitus (T2DM). Ninety T2DM patients will receive 250 ml yogurt drink fortified with 500 IU of vitamin D3 twice a day for 3 months. VDR Fok1 genotypes will be determined at the end of the study and the responses to vitamin D (metabolic, inflammatory and oxidative stress) will be compared between the three subgroups, i.e. FF, Ff and ff. To relate the possible changes in the indicators to the vitamin D intake, there will be a diabetic control group (n=30) who will receive the same amount of plain (unfortified) yogurt drink during the study period. The responses of the control group will be compared with those of 30 diabetic patients randomly selected from the fortified yogurt drink group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138810223006N2
Registration date:2010-04-27, 1389/02/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-04-27, 1389/02/07
Registrant information
Name
Tirang Reza Neyestani
Name of organization / entity
National nutrition and food technology research institute
Country
Iran (Islamic Republic of)
Phone
+98 21 2237 6471
Email address
t.neyestani@nnftri.ac.ir
Recruitment status
Recruitment complete
Funding source
1- National Nutrition & Food technology Research Institute , Shaheed Beheshti University of Medical Sciences & Health Services 2- School of Public health, Tehran University of Medical Sciences
Expected recruitment start date
2009-12-11, 1388/09/20
Expected recruitment end date
2010-03-20, 1388/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The role of vitamin D receptor (VDR) single nucleotide polymorphisms (SNPs ) in efficacy of vitamin D-fortified yogurt drink on metabolic-, inflammatory – and oxidative stress indicators in type 2 diabetic patients
Public title
Vitamin D receptor polymorphism , vitamin D-fortified Yogurt drink, Type 2 Diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Fasting blood glucose ≥ 126,
2. BMI between 25 to 35 kg/m2,
3. Age: 30-60 years old,
4. Willingness to maintain current body weight for the duration of the study,
5. Willingness to maintain baseline lifestyle activities and routines for the duration of the study,
6. Willingness to avoid the use of all over-the-counter or prescription vitamins, dietary supplements, and herbal products during the study.
Exclusion criteria:
1. History of cardiovascular disease, Gastrointestinal disease, Renal disease, Kidney stone, Hyperparathyroidism,
2. Receiving vitamin D or omega-3 supplement within the last three months,
3. Pregnancy , or lactation within the study period,
4. Receiving insulin or any drug for weight reduction, reducing serum cholesterol,
5. Any change in type /or dose of the current hypoglycemic medications,
Age
From 30 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of National Nutrition & Food technology Research Institute
Street address
No 46, Arghavan Gharbi, Farahzadi Blvd., Shahrak Qods (Gharb)