Type 2 Diabetes MellitusNCT01236846
Vitamin D Receptor Polymorphisms and Efficacy of Vitamin D-Fortified Yogurt Drink in Patients With Type 2 Diabetes
A study testing Fortified Yogurt Drink and Plain Yogurt Drink in people with Type 2 Diabetes Mellitus, run by Tirang R. Neyestani at 4 sites in Iran.
Trial summary
Study is a 12-week Double blind,controlled experiments designed to examine the possible effects of vitamin D receptor gene polymorphisms on the metabolic, inflammatory and oxidative stress markers in type 2 diabetic patients to vitamin D-fortified yogurt drink intake. Read more about this study
- Who is it for?
- Ages 30 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Fortified Yogurt Drink and Plain Yogurt Drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 4 sitesIran
- Study dates
- Oct 2009to Apr 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Type 2 diabetes
- Informed consent
- BMI between 25 to 35 kg/m2
- Age: 30-45 years old
- Willingness to maintain current body weight for the duration of the study
- Willingness to maintain baseline lifestyle activities and routines for the duration of the study
- Willingness to avoid the use of all over-the-counter or prescription vitamins, dietary supplements, and herbal products during the study
Who cannot join
- History of cardiovascular , Gastrointestinal , Renal disease and any other endocrinological disorders
- Subjects receiving vitamin D or omega-3 supplement
- Pregnancy , or lactation within the study period
- Treatment with insulin
- Treatment for weight reduction
- Treatment for reducing serum lipids
Trial locations and contacts
4 sites in 1 country.
Iran4 sites
National Nutrition and Food Technology Research Institute
Tehran, Tehran Province, 19395-4741
National Nutrition and Food Technology Research Institute
Tehran, Tehran Province, 1981619573
Tirang Neyestani
Tehran, Tehran Province
Study site
Tehran
About this study
Official title: Determination of VDR Single Nucleotide Polymorphisms (SNPs ) and Their Rols in Efficacy of Vitamin D-fortified Yogurt Drink on the Metabolic-, Inflammatory - and Oxidative Stress Parameters in Type 2 Diabetic Patients
Study is a 12-week Double blind,controlled experiments designed to examine the possible effects of vitamin D receptor gene polymorphisms on the metabolic, inflammatory and oxidative stress markers in type 2 diabetic patients to vitamin D-fortified yogurt drink intake.
Read the detailed description
In a 12-week randomized controlled trial ( double-blind study), based on data on serum 25(OH)D changes from other studies (35), to achieve 1 standard deviation difference in circulating 25(OH)D with two-sided alpha of 0.05 and a beta of 0.2 after a 12-week intervention period, the sample size was calculated 40 individuals per treatment group. Considering 3 polymorphic variant groups and one control group which receives plain yogurt drink, 160 subjects are needed. Allowing for 10% attrition over 12 weeks of intervention, a total of 180 subjects are required. In treatment groups, all patients receive 500 ml per day of low-fat (1%) Yogurt Drink fortified with approximately 500IU of vitamin D3 . Control group receives 500 ml per day of plain (unfortified) Yogurt Drink. Metabolic, inflammatory and oxidative stress markers are evaluated at the beginning and in the end of the interventional period.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Fortified Yogurt Drink, Plain Yogurt Drink
- Keywords
- Vitamin D fortification, Yogurt Drink, Efficacy
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fortified Yogurt DrinkDietary supplement
Also called FYD
Daily intake of yogurt drink fortified (500 ml) with 1000IU vitamin D for 12 weeks
Plain Yogurt DrinkDietary supplement
Also called PYD
Daily intake of unfortified yogurt drink(500 ml)for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Plain Yogurt Drink | Placebo comparator | Daily intake of unfortified yogurt drink(500 ml) for 12 weeks Receives: Dietary Supplement: Plain Yogurt Drink |
| VDR Genotype (aa) | Experimental | Daily intake of yogurt drink fortified (500 ml) with 1000IU vitamin D for 12 weeks Receives: Dietary Supplement: Fortified Yogurt Drink |
| VDR Genotype (AA) | Experimental | Daily intake of yogurt drink fortified (500 ml) with 1000 IU vitamin D for 12 weeks Receives: Dietary Supplement: Fortified Yogurt Drink |
| VDR genotype (Aa) | Experimental | Daily intake of yogurt drink fortified (500 ml) with 1000IU vitamin D for 12 weeks Receives: Dietary Supplement: Fortified Yogurt Drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum 25-hydroxyvitamin D
Measured: 3 months
Secondary outcomes (5)
Glycemic control
Measured: 3 Months
Inflammatory markers
Measured: 3 Months
Oxidative stress markers
Measured: 3 Months
Lipid profiles
Measured: 3 Months
Blood pressure
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2010 (estimated)
- Study startOct 2009
- Primary completionMar 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tirang R. Neyestani
- Sponsor type
- University, hospital or other
- Collaborators
- Tehran University of Medical Sciences
- Responsible party
- Sponsor-investigator, Tirang R. Neyestani, National Nutrition and Food Technology Institute
- Investigators
- Tirang R. Neyestani, Ph.D., Study chair, National Nutrition & Food technology Research institute, P.O. Box 19395-4741Abolghasem Djazayeri, Professor, Study chair, Tehran University of Medical SciencesSakineh Shab-Bidar, M.Sc., Principal investigator, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01236846
- Sponsor's protocol ID
- ABT-1236-RV
- Status last verified
- Apr 2012
- First submitted
- 9 Aug 2010
- Last updated
- 26 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Neyestani TR, Djazayery A, Shab-Bidar S, Eshraghian MR, Kalayi A, Shariatzadeh N, Khalaji N, Zahedirad M, Gharavi A, Houshiarrad A, Chamari M, Asadzadeh S. Vitamin D Receptor Fok-I polymorphism modulates diabetic host response to vitamin D intake: need for a nutrigenetic approach. Diabetes Care. 2013 Mar;36(3):550-6. doi: 10.2337/dc12-0919. Epub 2012 Nov 16.
PubMed 23160722Shab-Bidar S, Neyestani TR, Djazayery A, Eshraghian MR, Houshiarrad A, Kalayi A, Shariatzadeh N, Khalaji N, Gharavi A. Improvement of vitamin D status resulted in amelioration of biomarkers of systemic inflammation in the subjects with type 2 diabetes. Diabetes Metab Res Rev. 2012 Jul;28(5):424-30. doi: 10.1002/dmrr.2290. Epub 2012 Feb 17.
PubMed 22344966Shab-Bidar S, Neyestani TR, Djazayery A, Eshraghian MR, Houshiarrad A, Gharavi A, Kalayi A, Shariatzadeh N, Zahedirad M, Khalaji N, Haidari H. Regular consumption of vitamin D-fortified yogurt drink (Doogh) improved endothelial biomarkers in subjects with type 2 diabetes: a randomized double-blind clinical trial. BMC Med. 2011 Nov 24;9:125. doi: 10.1186/1741-7015-9-125.
PubMed 22114787Shab-Bidar S, Neyestani TR, Djazayery A. Efficacy of vitamin D3-fortified-yogurt drink on anthropometric, metabolic, inflammatory and oxidative stress biomarkers according to vitamin D receptor gene polymorphisms in type 2 diabetic patients: a study protocol for a randomized controlled clinical trial. BMC Endocr Disord. 2011 Jun 22;11:12. doi: 10.1186/1472-6823-11-12.
PubMed 21696575
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of VDR Single Nucleotide Polymorphisms (SNPs ) and Their Rols in Efficacy of Vitamin D-fortified Yogurt Drink on the Metabolic-, Inflammatory - and Oxidative Stress Parameters in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT01236846
- Acronym / sponsor ID
- ABT-1236-RV
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Vitamin D fortification, Yogurt Drink, Efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Tirang R. NeyestaniUniversity, hospital or other
- Collaborators
- Tehran University of Medical Sciences
- Study start
- Oct 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 9 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study is a 12-week Double blind,controlled experiments designed to examine the possible effects of vitamin D receptor gene polymorphisms on the metabolic, inflammatory and oxidative stress markers in type 2 diabetic patients to vitamin D-fortified yogurt drink intake.
Detailed description
In a 12-week randomized controlled trial ( double-blind study), based on data on serum 25(OH)D changes from other studies (35), to achieve 1 standard deviation difference in circulating 25(OH)D with two-sided alpha of 0.05 and a beta of 0.2 after a 12-week intervention period, the sample size was calculated 40 individuals per treatment group. Considering 3 polymorphic variant groups and one control group which receives plain yogurt drink, 160 subjects are needed. Allowing for 10% attrition over 12 weeks of intervention, a total of 180 subjects are required. In treatment groups, all patients receive 500 ml per day of low-fat (1%) Yogurt Drink fortified with approximately 500IU of vitamin D3 . Control group receives 500 ml per day of plain (unfortified) Yogurt Drink. Metabolic, inflammatory and oxidative stress markers are evaluated at the beginning and in the end of the interventional period.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Plain Yogurt Drink | Placebo comparator | Dietary Supplement: Plain Yogurt DrinkDaily intake of unfortified yogurt drink(500 ml) for 12 weeks |
| VDR Genotype (aa) | Experimental | Dietary Supplement: Fortified Yogurt DrinkDaily intake of yogurt drink fortified (500 ml) with 1000IU vitamin D for 12 weeks |
| VDR Genotype (AA) | Experimental | Dietary Supplement: Fortified Yogurt DrinkDaily intake of yogurt drink fortified (500 ml) with 1000 IU vitamin D for 12 weeks |
| VDR genotype (Aa) | Experimental | Dietary Supplement: Fortified Yogurt DrinkDaily intake of yogurt drink fortified (500 ml) with 1000IU vitamin D for 12 weeks |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Type 2 diabetes
- Informed consent
- BMI between 25 to 35 kg/m2
- Age: 30-45 years old
- Willingness to maintain current body weight for the duration of the study
Key exclusion criteria (6 listed)
- History of cardiovascular , Gastrointestinal , Renal disease and any other endocrinological disorders
- Subjects receiving vitamin D or omega-3 supplement
- Pregnancy , or lactation within the study period
- Treatment with insulin
- Treatment for weight reduction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fortified Yogurt DrinkAlso: FYDDaily intake of yogurt drink fortified (500 ml) with 1000IU vitamin D for 12 weeks | Dietary supplement | VDR Genotype (AA), VDR Genotype (aa), VDR genotype (Aa) |
| Plain Yogurt DrinkAlso: PYDDaily intake of unfortified yogurt drink(500 ml)for 12 weeks | Dietary supplement | Plain Yogurt Drink |
Primary outcome
serum 25-hydroxyvitamin D
Time frame: 3 months
5 secondary outcomes
Glycemic control
Time frame: 3 Months
Inflammatory markers
Time frame: 3 Months
Oxidative stress markers
Time frame: 3 Months
Lipid profiles
Time frame: 3 Months
Blood pressure
Time frame: 3 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2012.
- Derived from this study: PubMed 23160722Neyestani TR, Djazayery A, Shab-Bidar S, Eshraghian MR, Kalayi A, Shariatzadeh N, Khalaji N, Zahedirad M, Gharavi A, Houshiarrad A, Chamari M, Asadzadeh S. Vitamin D Receptor Fok-I polymorphism modulates diabetic host response to vitamin D intake: need for a nutrigenetic approach. Diabetes Care. 2013 Mar;36(3):550-6. doi: 10.2337/dc12-0919. Epub 2012 Nov 16.
- Derived from this study: PubMed 22344966Shab-Bidar S, Neyestani TR, Djazayery A, Eshraghian MR, Houshiarrad A, Kalayi A, Shariatzadeh N, Khalaji N, Gharavi A. Improvement of vitamin D status resulted in amelioration of biomarkers of systemic inflammation in the subjects with type 2 diabetes. Diabetes Metab Res Rev. 2012 Jul;28(5):424-30. doi: 10.1002/dmrr.2290. Epub 2012 Feb 17.
- Derived from this study: PubMed 22114787Shab-Bidar S, Neyestani TR, Djazayery A, Eshraghian MR, Houshiarrad A, Gharavi A, Kalayi A, Shariatzadeh N, Zahedirad M, Khalaji N, Haidari H. Regular consumption of vitamin D-fortified yogurt drink (Doogh) improved endothelial biomarkers in subjects with type 2 diabetes: a randomized double-blind clinical trial. BMC Med. 2011 Nov 24;9:125. doi: 10.1186/1741-7015-9-125.
- Derived from this study: PubMed 21696575Shab-Bidar S, Neyestani TR, Djazayery A. Efficacy of vitamin D3-fortified-yogurt drink on anthropometric, metabolic, inflammatory and oxidative stress biomarkers according to vitamin D receptor gene polymorphisms in type 2 diabetic patients: a study protocol for a randomized controlled clinical trial. BMC Endocr Disord. 2011 Jun 22;11:12. doi: 10.1186/1472-6823-11-12.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tirang R. Neyestani, Ph.D. study chair
National Nutrition & Food technology Research institute, P.O. Box 19395-4741
Abolghasem Djazayeri, Professor study chair
Tehran University of Medical Sciences
Sakineh Shab-Bidar, M.Sc. principal investigator
Tehran University of Medical Sciences
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fortified Yogurt Drink and Plain Yogurt Drink in people with Type 2 Diabetes Mellitus, run by Tirang R. Neyestani at 4 sites in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum 25-hydroxyvitamin D (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01236846, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2012.