Clinical trial NCT01510665: Magnesium Supplementation in the Second Trimester of Pregnancy to Overweight and Obese Individuals
Official title: Magnesium Supplementation in the Second Trimester of Pregnancy for Overweight Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
Obesity
Keywords: Weight gain in pregnancy
Metabolic and Inflammatory markers
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2012-01-16
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in maternal biomarkers during pregnancy up to 28 weeks
timeFrame: up to 28 weeks
measure: Neonatal birth weight/height
timeFrame: Up to 10 months
measure: Change in maternal biomarkers in pregnancy in the third trimester
timeFrame: Up to 36 weeks
Secondary outcomes:
measure: Neonatal outcomes
timeFrame: Up to 10 months
measure: Neonatal tertiary outcomes
timeFrame: Up to 10 months
measure: Pregnancy complications
timeFrame: Up to 10 months
Other outcomes:
Locations:
city: Westwood
country: United States
facility: 200 Medical Plaza UCLA Ob/Gyn Clinic
state: California
city: Westwood
country: United States
facility: West Medical UCLA Ob/Gyn Clinic
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Simin Liu, MD, ScD, MS, MPH
role: PRINCIPAL_INVESTIGATOR
References: