Comparison of Efficacy of Vitamin D and Vitamin D-calcium Fortified Yogurt Drink in Diabetic Patients

NCT ID: NCT01229891

Last Updated: 2012-01-16

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-09-30

Brief Summary

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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

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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

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Plain yogurt drink

daily intake of two bottle (250 mL) plain yogurt drink

Group Type PLACEBO_COMPARATOR

plain yogurt drink

Intervention Type DIETARY_SUPPLEMENT

daily intake of two bottle of plain yogurt drink

vitamin D-fortified yogurt drink

daily intake of two bottle yogurt drink fortified with 500 IU vitamin D/250 mL

Group Type EXPERIMENTAL

vitamin D fortified yogurt drink

Intervention Type DIETARY_SUPPLEMENT

daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D/250 mL

vitamin D-calcium yogurt drink

daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D and 250 mg calcium/250 mL

Group Type EXPERIMENTAL

vitamin D-calcium yogurt drink

Intervention Type DIETARY_SUPPLEMENT

daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D and 250 mg calcium/250 ml package

Interventions

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plain yogurt drink

daily intake of two bottle of plain yogurt drink

Intervention Type DIETARY_SUPPLEMENT

vitamin D fortified yogurt drink

daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D/250 mL

Intervention Type DIETARY_SUPPLEMENT

vitamin D-calcium yogurt drink

daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D and 250 mg calcium/250 ml package

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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PY DY DCY

Eligibility Criteria

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Inclusion Criteria

* 30 to 50 years,
* Fasting blood glucose ≥ 126 mg/dl

Exclusion Criteria

* 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
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Nutrition and Food Technology Institute

OTHER

Sponsor Role lead

Responsible Party

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Tirang R. Neyestani

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tirang R. Neyestani, PhD

Role: STUDY_CHAIR

National Nutrition and Food Technology Research Institute

References

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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.

Reference Type DERIVED
PMID: 34077684 (View on PubMed)

Heravifard 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.

Reference Type DERIVED
PMID: 23875809 (View on PubMed)

Neyestani 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.

Reference Type DERIVED
PMID: 22442277 (View on PubMed)

Nikooyeh 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.

Reference Type DERIVED
PMID: 21289226 (View on PubMed)

Other Identifiers

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11024

Identifier Type: -

Identifier Source: org_study_id

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