Type 2 DiabetesPhase 2NCT01229891
Comparison of Efficacy of Vitamin D and Vitamin D-calcium Fortified Yogurt Drink in Diabetic Patients
A Phase 2 study testing plain yogurt drink, vitamin D fortified yogurt drink and vitamin D-calcium yogurt drink in people with Type 2 Diabetes, run by National Nutrition and Food Technology Institute.
Trial summary
The aim of this study is to evaluate the possible effects of daily intake of yogurt drink fortified with vitamin D alone or with vitamin D + calcium on some selected glycemic, metabolic, inflammatory and oxidative stress markers in patients with type 2 diabetes (T2DM). Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- plain yogurt drink, vitamin D fortified yogurt drink and vitamin D-calcium yogurt drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Sep 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 30 to 50 years,
- Fasting blood glucose ≥ 126 mg/dl
Who cannot join
- Receiving vitamin D or calcium or omega-3 supplements within the last three months,
- On any medication which could potentially influence vitamin D metabolism (notably estrogens, and calcitonin) within the last three months,
- Any other concomitant disease such as renal, hepatic, and other endocrinological disorders, and malignancies, which could influence vitamin D metabolism.
- Receiving insulin or any change in the type and/or dose of the current hypoglycemic medications
About this study
Official title: Comparison of Efficacy of Vitamin D and Vitamin D-calcium Fortified Yogurt Drink on Glycemic, Metabolic, Inflammatory, Immunity and Oxidative Stress Markers in Type 2 Diabetes
The aim of this study is to evaluate the possible effects of daily intake of yogurt drink fortified with vitamin D alone or with vitamin D + calcium on some selected glycemic, metabolic, inflammatory and oxidative stress markers in patients with type 2 diabetes (T2DM).
Read the detailed description
ninety diabetic patients will be selected. Patients who are receiving vitamin D, calcium or omega-3 supplements within the last three months will be excluded. Patients will be assigned randomly to one of the three intervention groups. 1. Plain yogurt drink 2. Vitamin D-fortified yogurt drink 3. Vitamin D-calcium fortified yogurt drink. Each patient will consume 2 servings of yogurt drink every day for 3 months with lunch and dinner. At the first and last visits, dietary and laboratory assessments will be performed for all patients. Primary outcomes are improvement in glycemic, inflammatory and immunity markers and secondary outcome is prevention of long-term diabetic complications.
- Conditions
- Type 2 Diabetes
- Being tested
- plain yogurt drink, vitamin D fortified yogurt drink, vitamin D-calcium yogurt drink
- Keywords
- vitamin D fortification, yogurt drink, type 2 diabetes, 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.
plain yogurt drinkDietary supplement
Also called PY
daily intake of two bottle of plain yogurt drink
vitamin D fortified yogurt drinkDietary supplement
Also called DY
daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D/250 mL
vitamin D-calcium yogurt drinkDietary supplement
Also called DCY
daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D and 250 mg calcium/250 ml package
| Study group | Role | What they receive |
|---|---|---|
| Plain yogurt drink | Placebo comparator | daily intake of two bottle (250 mL) plain yogurt drink Receives: Dietary Supplement: plain yogurt drink |
| vitamin D-fortified yogurt drink | Experimental | daily intake of two bottle yogurt drink fortified with 500 IU vitamin D/250 mL Receives: Dietary Supplement: vitamin D fortified yogurt drink |
| vitamin D-calcium yogurt drink | Experimental | daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D and 250 mg calcium/250 mL Receives: Dietary Supplement: vitamin D-calcium yogurt drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum 25-hydroxyvitamin D
Measured: 12-week
Secondary outcomes (7)
Fasting Serum Glucose (FSG)
Measured: 12-week
Insulin
fasting serum insulin concentration
Measured: 12-week
Hemoglobin A1c (HbA1c)
Measured: 12-week
Serum Triglyceride (TG)
Measured: 12-week
Serum Total Cholesterol (Tchol)
Measured: 12-week
Serum Low Density Lipoprotein (LDL)
Measured: 12-week
Serum High Density Lipoprotein (HDL)
Measured: 12-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2010 (estimated)
- Study startOct 2009
- Primary completionMar 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Nutrition and Food Technology Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tirang R. Neyestani, National Nutrition and Food Technology Institute
- Investigators
- Tirang R. Neyestani, PhD, Study chair, National Nutrition and Food Technology Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01229891
- Sponsor's protocol ID
- 11024
- Status last verified
- Dec 2011
- First submitted
- 27 Oct 2010
- Last updated
- 16 Jan 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Nikooyeh B, Shariatzadeh N, Rismanchi M, Hollis BW, Neyestani TR. Daily intake of yogurt drink fortified either with vitamin D alone or in combination with added calcium causes a thyroid-independent increase of resting metabolic rate in adults with type 2 diabetes: a randomized, double-blind, clinical trial. Appl Physiol Nutr Metab. 2021 Nov;46(11):1363-1369. doi: 10.1139/apnm-2021-0248. Epub 2021 Jun 2.
PubMed 34077684Heravifard S, Neyestani TR, Nikooyeh B, Alavi-Majd H, Houshiarrad A, Kalayi A, Shariatzadeh N, Zahedirad M, Tayebinejad N, Salekzamani S, Khalaji N, Gharavi A. Regular consumption of both vitamin D- and calcium- and vitamin D-fortified yogurt drink is equally accompanied by lowered blood lipoprotein (a) and elevated apoprotein A1 in subjects with type 2 diabetes: a randomized clinical trial. J Am Coll Nutr. 2013;32(1):26-30. doi: 10.1080/07315724.2013.767659.
PubMed 23875809Neyestani TR, Nikooyeh B, Alavi-Majd H, Shariatzadeh N, Kalayi A, Tayebinejad N, Heravifard S, Salekzamani S, Zahedirad M. Improvement of vitamin D status via daily intake of fortified yogurt drink either with or without extra calcium ameliorates systemic inflammatory biomarkers, including adipokines, in the subjects with type 2 diabetes. J Clin Endocrinol Metab. 2012 Jun;97(6):2005-11. doi: 10.1210/jc.2011-3465. Epub 2012 Mar 22.
PubMed 22442277Nikooyeh B, Neyestani TR, Farvid M, Alavi-Majd H, Houshiarrad A, Kalayi A, Shariatzadeh N, Gharavi A, Heravifard S, Tayebinejad N, Salekzamani S, Zahedirad M. Daily consumption of vitamin D- or vitamin D + calcium-fortified yogurt drink improved glycemic control in patients with type 2 diabetes: a randomized clinical trial. Am J Clin Nutr. 2011 Apr;93(4):764-71. doi: 10.3945/ajcn.110.007336. Epub 2011 Feb 2.
PubMed 21289226
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Vitamin D and Vitamin D-calcium Fortified Yogurt Drink on Glycemic, Metabolic, Inflammatory, Immunity and Oxidative Stress Markers in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01229891
- Acronym / sponsor ID
- 11024
- Conditions
- Type 2 Diabetes
- Keywords
- vitamin D fortification, yogurt drink, type 2 diabetes, efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- National Nutrition and Food Technology InstituteUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 28 Oct 2010 (estimated)
- Results
- Posted 16 Jan 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the possible effects of daily intake of yogurt drink fortified with vitamin D alone or with vitamin D + calcium on some selected glycemic, metabolic, inflammatory and oxidative stress markers in patients with type 2 diabetes (T2DM).
Detailed description
ninety diabetic patients will be selected. Patients who are receiving vitamin D, calcium or omega-3 supplements within the last three months will be excluded. Patients will be assigned randomly to one of the three intervention groups. 1. Plain yogurt drink 2. Vitamin D-fortified yogurt drink 3. Vitamin D-calcium fortified yogurt drink. Each patient will consume 2 servings of yogurt drink every day for 3 months with lunch and dinner. At the first and last visits, dietary and laboratory assessments will be performed for all patients. Primary outcomes are improvement in glycemic, inflammatory and immunity markers and secondary outcome is prevention of long-term diabetic complications.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Plain yogurt drink | Placebo comparator | Dietary Supplement: plain yogurt drinkdaily intake of two bottle (250 mL) plain yogurt drink |
| vitamin D-fortified yogurt drink | Experimental | Dietary Supplement: vitamin D fortified yogurt drinkdaily intake of two bottle yogurt drink fortified with 500 IU vitamin D/250 mL |
| vitamin D-calcium yogurt drink | Experimental | Dietary Supplement: vitamin D-calcium yogurt drinkdaily intake of two bottle of yogurt drink fortified with 500 IU vitamin D and 250 mg calcium/250 mL |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 30 to 50 years,
- Fasting blood glucose ≥ 126 mg/dl
Key exclusion criteria (4 listed)
- Receiving vitamin D or calcium or omega-3 supplements within the last three months,
- On any medication which could potentially influence vitamin D metabolism (notably estrogens, and calcitonin) within the last three months,
- Any other concomitant disease such as renal, hepatic, and other endocrinological disorders, and malignancies, which could influence vitamin D metabolism.
- Receiving insulin or any change in the type and/or dose of the current hypoglycemic medications
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 |
|---|---|---|
| plain yogurt drinkAlso: PYdaily intake of two bottle of plain yogurt drink | Dietary supplement | Plain yogurt drink |
| vitamin D fortified yogurt drinkAlso: DYdaily intake of two bottle of yogurt drink fortified with 500 IU vitamin D/250 mL | Dietary supplement | vitamin D-fortified yogurt drink |
| vitamin D-calcium yogurt drinkAlso: DCYdaily intake of two bottle of yogurt drink fortified with 500 IU vitamin D and 250 mg calcium/250 ml package | Dietary supplement | vitamin D-calcium yogurt drink |
Primary outcome
Serum 25-hydroxyvitamin D
Time frame: 12-week
7 secondary outcomes
Fasting Serum Glucose (FSG)
Time frame: 12-week
Insulin
Time frame: 12-week
Hemoglobin A1c (HbA1c)
Time frame: 12-week
Serum Triglyceride (TG)
Time frame: 12-week
Serum Total Cholesterol (Tchol)
Time frame: 12-week
Serum Low Density Lipoprotein (LDL)
Time frame: 12-week
Serum High Density Lipoprotein (HDL)
Time frame: 12-week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34077684Nikooyeh B, Shariatzadeh N, Rismanchi M, Hollis BW, Neyestani TR. Daily intake of yogurt drink fortified either with vitamin D alone or in combination with added calcium causes a thyroid-independent increase of resting metabolic rate in adults with type 2 diabetes: a randomized, double-blind, clinical trial. Appl Physiol Nutr Metab. 2021 Nov;46(11):1363-1369. doi: 10.1139/apnm-2021-0248. Epub 2021 Jun 2.
- Derived from this study: PubMed 23875809Heravifard S, Neyestani TR, Nikooyeh B, Alavi-Majd H, Houshiarrad A, Kalayi A, Shariatzadeh N, Zahedirad M, Tayebinejad N, Salekzamani S, Khalaji N, Gharavi A. Regular consumption of both vitamin D- and calcium- and vitamin D-fortified yogurt drink is equally accompanied by lowered blood lipoprotein (a) and elevated apoprotein A1 in subjects with type 2 diabetes: a randomized clinical trial. J Am Coll Nutr. 2013;32(1):26-30. doi: 10.1080/07315724.2013.767659.
- Derived from this study: PubMed 22442277Neyestani TR, Nikooyeh B, Alavi-Majd H, Shariatzadeh N, Kalayi A, Tayebinejad N, Heravifard S, Salekzamani S, Zahedirad M. Improvement of vitamin D status via daily intake of fortified yogurt drink either with or without extra calcium ameliorates systemic inflammatory biomarkers, including adipokines, in the subjects with type 2 diabetes. J Clin Endocrinol Metab. 2012 Jun;97(6):2005-11. doi: 10.1210/jc.2011-3465. Epub 2012 Mar 22.
- Derived from this study: PubMed 21289226Nikooyeh B, Neyestani TR, Farvid M, Alavi-Majd H, Houshiarrad A, Kalayi A, Shariatzadeh N, Gharavi A, Heravifard S, Tayebinejad N, Salekzamani S, Zahedirad M. Daily consumption of vitamin D- or vitamin D + calcium-fortified yogurt drink improved glycemic control in patients with type 2 diabetes: a randomized clinical trial. Am J Clin Nutr. 2011 Apr;93(4):764-71. doi: 10.3945/ajcn.110.007336. Epub 2011 Feb 2.
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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, PhD study chair
National Nutrition and Food Technology Research Institute
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing plain yogurt drink, vitamin D fortified yogurt drink and vitamin D-calcium yogurt drink in people with Type 2 Diabetes, run by National Nutrition and Food Technology Institute.
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 2 inclusion and 4 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 16 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: 12-week). 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 NCT01229891, 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 16 Jan 2012.