Magnesium Supplementation in the Second Trimester of Pregnancy to Overweight and Obese Individuals
|ClinicalTrials.gov Identifier: NCT01510665|
Recruitment Status : Completed
First Posted : January 16, 2012
Last Update Posted : June 14, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Gestational Diabetes Obesity||Dietary Supplement: Magnesium citrate Dietary Supplement: Placebo Behavioral: Dietary modification||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Magnesium Supplementation in the Second Trimester of Pregnancy for Overweight Individuals|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
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
- Change in maternal biomarkers during pregnancy up to 28 weeks [ Time Frame: 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.
- Neonatal birth weight/height [ Time Frame: Up to 10 months ]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.
- Change in maternal biomarkers in pregnancy in the third trimester [ Time Frame: Up to 36 weeks ]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.
- Neonatal outcomes [ Time Frame: Up to 10 months ]
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.
- Neonatal tertiary outcomes [ Time Frame: Up to 10 months ]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.
- Pregnancy complications [ Time Frame: Up to 10 months ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01510665
|United States, California|
|200 Medical Plaza UCLA Ob/Gyn Clinic|
|Westwood, California, United States, 90095|
|West Medical UCLA Ob/Gyn Clinic|
|Westwood, California, United States, 90095|
|Principal Investigator:||Simin Liu, MD, ScD, MS, MPH||University of California, Los Angeles|