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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Gestational Diabetes
• Intervention / Treatment: Dietary supplement: Magnesium citrate; Dietary supplement: Placebo; Behavioral: Dietary modification

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Westwood, California, United States, 90095
      • 200 Medical Plaza UCLA Ob/Gyn Clinic
    • Westwood, California, United States, 90095
      • West Medical UCLA Ob/Gyn Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Magnesium Supplement; Magnesium citrate dietary supplement (300 mg elemental Magnesium daily dose) given week 13 to week 28 (two pills daily)	Dietary supplement: Magnesium citrate; Magnesium citrate tablets 950 mg, two pills once daily (Total daily dose of 300 mg elemental magnesium)
Placebo Comparator: Placebo; Identical appearing pill with inactive ingredients given week 13 to week 28 (two pills daily)	Dietary supplement: Placebo; Identical appearing placebo with inactive ingredients, two pills once daily.
Active Comparator: Diet; Nutritionist counseling session and advice on following a magnesium rich diet from week 13 to week 28	Behavioral: Dietary modification; Nutritionist counseling session and advice on following a magnesium rich diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in maternal biomarkers during pregnancy up to 28 weeks	Blood and urine markers of inflammatory and metabolic markers will be assessed during the pregnancy,comparing baseline values to second trimester values, which will be up to 28 weeks.	up to 28 weeks
Neonatal birth weight/height	This measure will be assessed at neonatal delivery, which will occur at a maximum of up to 10 months from randomization. Neonatal weight and height at birth will be assessed.	Up to 10 months
Change in maternal biomarkers in pregnancy in the third trimester	Blood and urine markers of inflammatory and metabolic markers will be assessed during the pregnancy,comparing baseline values to third trimester values, which will be up to 36 weeks.	Up to 36 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal outcomes	This measure will be assessed at neonatal delivery, which will occur at a maximum of up to 10 months from randomization. At delivery, neonatal characteristics will be assessed: Macrosomia, preterm birth, head circumference, and apgar score.	Up to 10 months
Neonatal tertiary outcomes	This measure will be assessed at neonatal delivery, which will occur at a maximum of up to 10 months from randomization. Cord blood and placenta will be collected at delivery, and we will examine endothelial progenitor cell presence in cord blood, PON expression in cord blood, and DNA expression from the placental tissue.	Up to 10 months
Pregnancy complications	From date of randomization until the date of delivery of the neonate, up to a maximum of 10 months, pregnancy complications such as development of gestational diabetes, hypertension, proteinuria, shoulder dystocia, cesarean section, as well as amount of weight gain will be assessed from the chart.	Up to 10 months

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Investigators: Principal Investigator: Simin Liu, MD, ScD, MS, MPH, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: December 23, 2011
• First Submitted That Met QC Criteria: January 13, 2012
• First Posted (Estimate): January 16, 2012

Study Record Updates

• Last Update Posted (Estimate): June 14, 2013
• Last Update Submitted That Met QC Criteria: June 12, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Weight gain in pregnancy; Metabolic and Inflammatory markers
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Body Weight; Pregnancy Complications; Overweight; Diabetes, Gestational; Gastrointestinal Agents; Cathartics; Magnesium citrate
• Other Study ID Numbers: Magnesium123