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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
History of Changes
  Purpose

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 Intervention
Gestational Diabetes
Obesity
 Dietary Supplement: Magnesium citrate
Dietary Supplement: Placebo
Behavioral: Dietary modification

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Magnesium Supplementation in the Second Trimester of Pregnancy for Overweight Individuals

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 28
Study Start Date: January 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01510665

Locations
United States, California
West Medical UCLA Ob/Gyn Clinic
Westwood, California, United States, 90095
200 Medical Plaza UCLA Ob/Gyn Clinic
Westwood, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Simin Liu, MD, ScD, MS, MPH University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Simin Liu, Dr., Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01510665     History of Changes
Other Study ID Numbers: Magnesium123
Study First Received: December 23, 2011
Last Updated: June 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Weight gain in pregnancy
Metabolic and Inflammatory markers

Additional relevant MeSH terms:
Obesity
Diabetes, Gestational
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Pregnancy Complications
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Citric Acid
Magnesium citrate
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Cathartics
Gastrointestinal Agents

ClinicalTrials.gov processed this record on June 13, 2013