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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01229891

Enrollment

Registered

2010-10-28

Start date

2009-10-31

Completion date

2010-09-30

Last updated

2012-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

vitamin D fortification, yogurt drink, type 2 diabetes, efficacy

Brief 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).

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.

Interventions

DIETARY_SUPPLEMENTplain yogurt drink

daily intake of two bottle of plain yogurt drink

DIETARY_SUPPLEMENTvitamin D fortified yogurt drink

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

DIETARY_SUPPLEMENTvitamin 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

30 Years to 60 Years

Healthy volunteers

Inclusion criteria

Age: * 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

Design outcomes

Primary

Measure	Time frame
Serum 25-hydroxyvitamin D	12-week

Secondary

Measure	Time frame	Description
Insulin	12-week	fasting serum insulin concentration
Hemoglobin A1c (HbA1c)	12-week	—
Serum Triglyceride (TG)	12-week	—
Fasting Serum Glucose (FSG)	12-week	—
Serum Low Density Lipoprotein (LDL)	12-week	—
Serum High Density Lipoprotein (HDL)	12-week	—
Serum Total Cholesterol (Tchol)	12-week	—

Participant flow

Participants by arm

Arm	Count
Plain Yogurt Drink daily intake of two bottle (250 mL) plain yogurt drink	30
Vitamin D-fortified Yogurt Drink daily intake of two bottle yogurt drink fortified with 500 IU vitamin D/250 mL	30
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	30
Total	90

Baseline characteristics

Characteristic	Plain Yogurt Drink	Vitamin D-fortified Yogurt Drink	Vitamin D-calcium Yogurt Drink	Total
25-hydroxyvitamin D	50 nmol/L STANDARD_DEVIATION 26	47.5 nmol/L STANDARD_DEVIATION 27	51.3 nmol/L STANDARD_DEVIATION 43	48.8 nmol/L STANDARD_DEVIATION 38.4
Age Continuous	50.8 years STANDARD_DEVIATION 6.6	51.4 years STANDARD_DEVIATION 5.4	49.9 years STANDARD_DEVIATION 6.2	50.7 years STANDARD_DEVIATION 6.1
Fasting serum glucose (FSG)	187 mg/dL STANDARD_DEVIATION 57.1	184.1 mg/dL STANDARD_DEVIATION 63.8	184 mg/dL STANDARD_DEVIATION 57.3	185 mg/dL STANDARD_DEVIATION 58.8
HbA1c	7.5 percent STANDARD_DEVIATION 1.5	7.4 percent STANDARD_DEVIATION 1.8	7.8 percent STANDARD_DEVIATION 1.9	7.6 percent STANDARD_DEVIATION 1.7
HDL	50.8 mg/dL STANDARD_DEVIATION 8.2	46 mg/dL STANDARD_DEVIATION 9.6	47.2 mg/dL STANDARD_DEVIATION 9.4	48 mg/dL STANDARD_DEVIATION 9.2
Insulin	7.7 mU/L STANDARD_DEVIATION 3.2	7.7 mU/L STANDARD_DEVIATION 4.6	7.6 mU/L STANDARD_DEVIATION 4.6	7.6 mU/L STANDARD_DEVIATION 4.1
LDL	88.6 mg/dL STANDARD_DEVIATION 25.9	87.2 mg/dL STANDARD_DEVIATION 25.1	90.2 mg/dL STANDARD_DEVIATION 27.9	88.7 mg/dL STANDARD_DEVIATION 26
Sex: Female, Male Female	18 Participants	16 Participants	9 Participants	43 Participants
Sex: Female, Male Male	12 Participants	14 Participants	21 Participants	47 Participants
Tchol	187.5 mg/dL STANDARD_DEVIATION 43.3	177.5 mg/dL STANDARD_DEVIATION 41.9	187.7 mg/dL STANDARD_DEVIATION 46.6	182.4 mg/dL STANDARD_DEVIATION 43.8
TG	160.5 mg/dL STANDARD_DEVIATION 100.7	155.4 mg/dL STANDARD_DEVIATION 65.9	176.6 mg/dL STANDARD_DEVIATION 91	164.2 mg/dL STANDARD_DEVIATION 86.6

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	0 / 30	0 / 30	0 / 30
serious Total, serious adverse events	0 / 30	0 / 30	0 / 30

Outcome results

Primary

Serum 25-hydroxyvitamin D

Time frame: 12-week

Arm	Measure	Value (MEAN)	Dispersion
Plain Yogurt Drink	Serum 25-hydroxyvitamin D	45.6 nmol/L	Standard Deviation 45.4
Vitamin D-fortified Yogurt Drink	Serum 25-hydroxyvitamin D	76.2 nmol/L	Standard Deviation 28.4
Vitamin D-calcium Fortified Yogurt Drink	Serum 25-hydroxyvitamin D	78.4 nmol/L	Standard Deviation 40.8

Secondary

Fasting Serum Glucose (FSG)

Time frame: 12-week

Arm	Measure	Value (MEAN)	Dispersion
Plain Yogurt Drink	Fasting Serum Glucose (FSG)	203.3 mg/dL	Standard Deviation 64.4
Vitamin D-fortified Yogurt Drink	Fasting Serum Glucose (FSG)	171.2 mg/dL	Standard Deviation 59.2
Vitamin D-calcium Fortified Yogurt Drink	Fasting Serum Glucose (FSG)	174.3 mg/dL	Standard Deviation 50

Secondary

Hemoglobin A1c (HbA1c)

Time frame: 12-week

Arm	Measure	Value (MEAN)	Dispersion
Plain Yogurt Drink	Hemoglobin A1c (HbA1c)	8.7 percent	Standard Deviation 1.4
Vitamin D-fortified Yogurt Drink	Hemoglobin A1c (HbA1c)	7 percent	Standard Deviation 2.3
Vitamin D-calcium Fortified Yogurt Drink	Hemoglobin A1c (HbA1c)	7.8 percent	Standard Deviation 1.9

Secondary

Insulin

fasting serum insulin concentration

Time frame: 12-week

Arm	Measure	Value (MEAN)	Dispersion
Plain Yogurt Drink	Insulin	10.8 mU/L	Standard Deviation 5.5
Vitamin D-fortified Yogurt Drink	Insulin	6.5 mU/L	Standard Deviation 3.3
Vitamin D-calcium Fortified Yogurt Drink	Insulin	6.4 mU/L	Standard Deviation 3.1

Secondary

Serum High Density Lipoprotein (HDL)

Time frame: 12-week

Arm	Measure	Value (MEAN)	Dispersion
Plain Yogurt Drink	Serum High Density Lipoprotein (HDL)	51.8 mg/dL	Standard Deviation 9.6
Vitamin D-fortified Yogurt Drink	Serum High Density Lipoprotein (HDL)	46.1 mg/dL	Standard Deviation 10
Vitamin D-calcium Fortified Yogurt Drink	Serum High Density Lipoprotein (HDL)	48 mg/dL	Standard Deviation 6.8

Secondary

Serum Low Density Lipoprotein (LDL)

Time frame: 12-week

Arm	Measure	Value (MEAN)	Dispersion
Plain Yogurt Drink	Serum Low Density Lipoprotein (LDL)	93.5 mg/dL	Standard Deviation 24.9
Vitamin D-fortified Yogurt Drink	Serum Low Density Lipoprotein (LDL)	91.1 mg/dL	Standard Deviation 19.8
Vitamin D-calcium Fortified Yogurt Drink	Serum Low Density Lipoprotein (LDL)	96.3 mg/dL	Standard Deviation 27.8

Secondary

Serum Total Cholesterol (Tchol)

Time frame: 12-week

Arm	Measure	Value (MEAN)	Dispersion
Plain Yogurt Drink	Serum Total Cholesterol (Tchol)	197.3 mg/dL	Standard Deviation 48.1
Vitamin D-fortified Yogurt Drink	Serum Total Cholesterol (Tchol)	182.8 mg/dL	Standard Deviation 43
Vitamin D-calcium Fortified Yogurt Drink	Serum Total Cholesterol (Tchol)	178.5 mg/dL	Standard Deviation 42.4

Secondary

Serum Triglyceride (TG)

Time frame: 12-week

Arm	Measure	Value (MEAN)	Dispersion
Plain Yogurt Drink	Serum Triglyceride (TG)	181.3 mg/dL	Standard Deviation 91.8
Vitamin D-fortified Yogurt Drink	Serum Triglyceride (TG)	155.2 mg/dL	Standard Deviation 55.1
Vitamin D-calcium Fortified Yogurt Drink	Serum Triglyceride (TG)	161.1 mg/dL	Standard Deviation 64.3

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026

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

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Participant flow

Participants by arm

Baseline characteristics

Adverse events

Outcome results

Serum 25-hydroxyvitamin D

Fasting Serum Glucose (FSG)

Hemoglobin A1c (HbA1c)

Insulin

Serum High Density Lipoprotein (HDL)

Serum Low Density Lipoprotein (LDL)

Serum Total Cholesterol (Tchol)

Serum Triglyceride (TG)