Vitamin D Supplementation and Pregnancy Outcomes
Vitamin D Supplementation and Pregnancy Outcomes
Groups (group 1 receives 1000 IU vitamin D and group 2 receives 2000 IU vitamin D) through a
 random allocation. It is necessary to mention that all cases in each group could be able to
 receive the current supplementation during pregnancy (Folic acid, iron and multivitamin and
 calcium). This study aimed to evaluate the efficacy of two doses of vitamin D supplementation
 (1000 and 2000 IU/d) during pregnancy on maternal and newborn vitamin D status and metabolic
 profile including lipid profile (serum concentration of total cholesterol (TC), low-density
 lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C),
 triglyceride(TG)), glucose homeostasis (fasting glucose, insulin, insulin resistance
 (HOMA-IR)) and inflammatory and oxidative stress (OS) markers and pregnancy outcomes
 including gestational diabetes, preeclampsia, preterm delivery, abortion, cesarian section,
 and also anthropometric data and apgar score of infants compared with placebo.
In this randomized controlled trial, 84 pregnant women aged at 18-40 years with gestational
 age of <12 weeks will be recruited and divided into 2 groups.

 Demographic, socioeconomic and lifestyle data as well as blood samples and urine samples will
 be collected at baseline and in the last month of pregnancy. Moreover the cord blood will be
 collected at birth.

 Fasting blood glucose, insulin resistance (HOMA-IR), insulin, lipid profile (serum
 concentration of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C),
 high-density lipoprotein cholesterol (HDL-C), triglyceride(TG)), inflammatory (IL-1β, IL-6,
 TNF-α, hs-CRP) and oxidative stress markers (MDA, TAC), calcium:creatinine ratio are going to
 be evaluated at the beginning and in the end of the interventional period in pregnant women.
 Inflammatory (IL-1β, IL-6, Tumor Necrosis Factor (TNF-α), hs-CRP) and oxidative stress
 markers (MDA, TAC) will be determined in cord blood as well.
Inclusion Criteria:

 -  maternal age of 18-40 years,

 -  gestational age of 12 weeks or less,

 -  singleton pregnancies,

 -  mothers supposed to have normal pregnancy and not having preexisting diseases like
 hypertension, or cardiac, renal, hepatic, autoimmune , rheumatoid arthritis and
 digestive disease, or endocrinological disorders including diabetes (type 1 or type 2
 diabetes), parathyroid disorders, and thyroid disorder,

 -  not receiving dietary supplements including vitamin D (>600 IU/d), or omega-3 within
 the past 3 months before the intervention,

 -  not taking medications that could potentially influence vitamin D metabolism,

 -  willingness to participate in the study.

 Exclusion Criteria:

 -  Participants who do not meet the inclusion criteria,

 -  those who diagnosed to have fasting blood sugar (FBS)>92 at first blood sampling
 and/or blood pressure > 140/90 mmHg at the first visit,

 -  using extra vitamin D3 supplement and/or omega-3 and/or other medications that could
 potentially influence vitamin D metabolism,

 -  fetal anomaly,

 -  poor adherence to the study protocol,

 -  unwillingness to continue the intervention.