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NCT Number: NCT01510665

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

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Key information

Conditions

Gestational Diabetes Body Weight Body Weight Changes Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Gestational Weight Gain Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pregnancy Complications Signs and Symptoms Urogenital Diseases Weight Gain

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

200 Medical Plaza UCLA Ob/Gyn Clinic, Westwood, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnesium citrate

Dietary Supplement

Magnesium citrate tablets 950 mg, two pills once daily (Total daily dose of 300 mg elemental magnesium)

Placebo

Dietary Supplement

Identical appearing placebo with inactive ingredients, two pills once daily.

Dietary Modification

Behavioral

Nutritionist counseling session and advice on following a magnesium rich diet

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Official study title

Magnesium Supplementation in the Second Trimester of Pregnancy for Overweight Individuals

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 16, 2012
Registry last updated
Jun 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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