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Study aim
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The purpose of this study is to determine the effect of Vitamin D oral supplementation on glycemic control, serum levels of Growth Hormone, Insulin-Like Growth Factor-1 and Lipid Profile in Gestational Diabetes Mellitus patients
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Design
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This is a randomized, double-blind, placebo-controlled clinical trial. The final sample includes 30 gestational diabetes patients who have been selected by convenience sampling method and will be placed randomly in two groups of intervention (n=15) and control (n=15). This study will be done within 6 weeks.
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Settings and conduct
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At the baseline and the end of study, blood samples will be collected and the growth hormone, Insulin-like growth factor-1, lipid profile and glycemic status in patients will be compared before and after the intervention.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: detection of Gestational Diabetes Between 24-28 weeks of pregnancy, tend to participate in the study, age category between 18-40 years old, consumption of daily multivitamins; Exclusion criteria: twin or multiple pregnancy, having a Body Mass Index greater than 40, consumption of Vitamin D supplementation at least three months before the intervention, consumption of Insulin or Metformin, people with cardiovascular diseases, digestive disorders, hypertension, inflammatory diseases and hypothyroidism due to the effect on insulin metabolism and lipid profile.
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Intervention groups
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The intervention group will receive one tab containing 2000 IU vitamin D3 daily for 6 weeks; The control group will receive one plasebo containing paraffin oil daily for 6 weeks.
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Main outcome variables
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Vitamin D, growth hormone, insulin like growth factor-1, glucose, insulin, Cholesterol, triglyceride