Magnesium Supplementation in the Second Trimester of Pregnancy to Overweight and Obese Individuals

Completed · Not applicable · Has a placebo group

Conditions studied: Gestational Diabetes, Obesity

In brief

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.

Key facts

Study ID

NCT01510665

Run by

University of California, Los Angeles

People needed

28

Starts

2012-01-01

Expected to finish

2013-06-01

Last updated by the study team

2013-06-14

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Between 18 and 40 years of age
• Pregnant in the first trimester
• Able to give informed consent
• Planning to deliver at UCLA
• BMI greater than or equal to 25

You may not qualify if…

• On insulin therapy or other oral hypoglycemic agents
• Multiple gestation
• Baseline HgbA1C > 6.5%
• Prior history of clinically diagnosed T2D
• Multiple dietary restrictions/food allergies
• Heart, renal, or liver failure
• Clinical history of psychiatric illness or substance abuse
• Out of town travel planned at study visits

Where it is running

• 200 Medical Plaza UCLA Ob/Gyn Clinic — Westwood, Los Angeles, California, United States
• West Medical UCLA Ob/Gyn Clinic — Westwood, Los Angeles, California, United States

Full record on ClinicalTrials.gov

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