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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Simin Liu, Dr., University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01510665
First received: December 23, 2011
Last updated: June 12, 2013
Last verified: June 2013

December 23, 2011
June 12, 2013
January 2012
June 2013   (final data collection date for primary outcome measure)
  • Change in maternal biomarkers during pregnancy up to 28 weeks [ Time Frame: up to 28 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Same as current
Complete list of historical versions of study NCT01510665 on ClinicalTrials.gov Archive Site
  • Neonatal outcomes [ Time Frame: Up to 10 months ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Gestational Diabetes
  • Obesity
  • Dietary Supplement: Magnesium citrate
    Magnesium citrate tablets 950 mg, two pills once daily (Total daily dose of 300 mg elemental magnesium)
  • Dietary Supplement: 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
  • Experimental: Magnesium Supplement
    Magnesium citrate dietary supplement (300 mg elemental Magnesium daily dose) given week 13 to week 28 (two pills daily)
    Intervention: Dietary Supplement: Magnesium citrate
  • Placebo Comparator: Placebo
    Identical appearing pill with inactive ingredients given week 13 to week 28 (two pills daily)
    Intervention: Dietary Supplement: Placebo
  • Active Comparator: Diet
    Nutritionist counseling session and advice on following a magnesium rich diet from week 13 to week 28
    Intervention: Behavioral: Dietary modification
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Female
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01510665
Magnesium123
No
Simin Liu, Dr., University of California, Los Angeles
University of California, Los Angeles
Not Provided
Principal Investigator: Simin Liu, MD, ScD, MS, MPH University of California, Los Angeles
University of California, Los Angeles
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP