Obesity Clinical Trial
Official title:
Magnesium Supplementation in the Second Trimester of Pregnancy for Overweight Individuals
This is a prospective, randomized, placebo controlled study with three parallel arms
examining the effects of magnesium supplementation in the second trimester of pregnancy.
Recent research has shown that supplemental magnesium can have beneficial effects,
especially in overweight individuals. Not only do many people have a magnesium deficient
diet, there is also evidence that magnesium can improve blood sugar levels. Due to the
growing concern of obesity with pregnancy and its associated complications, such as diabetes
and abnormal fetal growth, magnesium therapy could have novel and beneficial effects on
pregnancy outcomes.
In this study, 60 overweight and obese pregnant patients in their first trimester will be
enrolled and randomized. The first group (A) will receive oral magnesium citrate (300mg
elemental Magnesium), group B will receive dietary counseling about following a magnesium
rich diet from a nutritionist, and group C will receive a placebo (control). Blood and urine
specimens will be collected at three time points during the pregnancy to analyze changes in
levels of metabolic markers, inflammatory markers, and protein expression profiles. Fetal
and maternal complications of pregnancy will be noted, including maternal weight gain. At
delivery, patients will have a placental cord blood specimen and placental biopsy collected
for gene expression patterns and further analysis.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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