Maternal Vitamin D Status Clinical Trial
Official title:
Evaluation and Comparison of the Efficacy of 1000 and 2000 IU/d Vitamin D Supplementation During Pregnancy on Maternal and Newborn Vitamin D Status 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.
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Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT01630603 -
Maternal Vitamin D Status and Neonatal Bone Strength
|
N/A |