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Effect of vitamin D supplementation on the glycaemic status and body fat mass in prediabetic adults: a randomized placebo- controlled trial

Not Applicable
Completed
Conditions
Glucose-galactose malabsorption
Other disorders of intestinal carbohydrate absorption.
Registration Number
IRCT2016090529508N3
Lead Sponsor
Vice chancellor for research, Urmia University of Medical sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
120
Inclusion Criteria

prediabetic adults; vitamin D Insufficient; 30-70 age group
Exclusion criteria: any diseases which may affect vitamin D metabolism and status or blood glucose control; such as type 1 or type 2 diabetes; kidney diseases; sarcoidosis; cancers; hyperparathyroidism; heart diseases; liver diseases; pregnant and lactating women; poly cystic ovarian syndrome; hypercalcemia; inflammatory bowel disease; cystic fibrosis; gastric bypass surgery; cholecystectomy; serious pulmonary diseases; patients took anti - convulsants; digoxin; contraceptives; orlistat and vitamin D supplements within the last three months; smoking and drinking alcohol; patients who changed their lifestyle and dietary habits during the intervention period; having the threshold serum 25(OH)D of either D3 < 10 nmol/ml or > 150 nmol/ml; patients without informed consent and those who were taking less than 90% of the supplements given to take during the study.

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Fasting blood sugar (FBS). Timepoint: before intervention, 3 months after intervention. Method of measurement: mg/dl.;Glycated hemoglobin (HbA1c). Timepoint: before intervention, 3 months after intervention. Method of measurement: %, Gama.;Serum insulin. Timepoint: before intervention, 3 months after intervention. Method of measurement: mg/dl.;Percentage body fat mass. Timepoint: before intervention, 3 months after intervention. Method of measurement: %, kaliper.;Serum 25(OH)D. Timepoint: before intervention, 3 months after intervention. Method of measurement: ng/ml.;Homeostasis model assessment of insulin resistance (HOMA-IR). Timepoint: before intervention, 3 months after intervention. Method of measurement: FBS*Insulin.
Secondary Outcome Measures
NameTimeMethod
Daily sun exposure. Timepoint: before intervention, 3 months after intervention. Method of measurement: hour.;Waist Circumference. Timepoint: before intervention, 3 months after intervention. Method of measurement: cm.;Body Mass Index (BMI). Timepoint: before intervention, 3 months after intervention. Method of measurement: kg/m2.
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