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

Obesity Clinical Trial

Official title:

Magnesium Supplementation in the Second Trimester of Pregnancy for Overweight Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01510665
• Other study ID #: Magnesium123
• Status: Completed
• Phase: N/A
• First received: December 23, 2011
• Last updated: June 12, 2013
• Start date: January 2012
• Est. completion date: June 2013

Study information

• Verified date: June 2013
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes
• Obesity

Intervention

Dietary Supplement:
• Magnesium citrate
Magnesium citrate tablets 950 mg, two pills once daily (Total daily dose of 300 mg elemental magnesium)
• Placebo
Identical appearing placebo with inactive ingredients, two pills once daily.

Behavioral:
• Dietary modification
Nutritionist counseling session and advice on following a magnesium rich diet

Locations

Country	Name	City	State
United States	200 Medical Plaza UCLA Ob/Gyn Clinic	Westwood	California
United States	West Medical UCLA Ob/Gyn Clinic	Westwood	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No