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

Primary Purpose

Gestational Diabetes, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Magnesium citrate
Placebo
Dietary modification
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gestational Diabetes focused on measuring Weight gain in pregnancy, Metabolic and Inflammatory markers

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • 200 Medical Plaza UCLA Ob/Gyn Clinic
  • West Medical UCLA Ob/Gyn Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Magnesium Supplement

Placebo

Diet

Arm Description

Magnesium citrate dietary supplement (300 mg elemental Magnesium daily dose) given week 13 to week 28 (two pills daily)

Identical appearing pill with inactive ingredients given week 13 to week 28 (two pills daily)

Nutritionist counseling session and advice on following a magnesium rich diet from week 13 to week 28

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
December 23, 2011
Last Updated
June 12, 2013
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT01510665
Brief Title
Magnesium Supplementation in the Second Trimester of Pregnancy to Overweight and Obese Individuals
Official Title
Magnesium Supplementation in the Second Trimester of Pregnancy for Overweight Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes, Obesity
Keywords
Weight gain in pregnancy, Metabolic and Inflammatory markers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Magnesium Supplement
Arm Type
Experimental
Arm Description
Magnesium citrate dietary supplement (300 mg elemental Magnesium daily dose) given week 13 to week 28 (two pills daily)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Identical appearing pill with inactive ingredients given week 13 to week 28 (two pills daily)
Arm Title
Diet
Arm Type
Active Comparator
Arm Description
Nutritionist counseling session and advice on following a magnesium rich diet from week 13 to week 28
Intervention Type
Dietary Supplement
Intervention Name(s)
Magnesium citrate
Intervention Description
Magnesium citrate tablets 950 mg, two pills once daily (Total daily dose of 300 mg elemental magnesium)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Identical appearing placebo with inactive ingredients, two pills once daily.
Intervention Type
Behavioral
Intervention Name(s)
Dietary modification
Intervention Description
Nutritionist counseling session and advice on following a magnesium rich diet
Primary Outcome Measure Information:
Title
Change in maternal biomarkers during pregnancy up to 28 weeks
Description
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.
Time Frame
up to 28 weeks
Title
Neonatal birth weight/height
Description
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.
Time Frame
Up to 10 months
Title
Change in maternal biomarkers in pregnancy in the third trimester
Description
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.
Time Frame
Up to 36 weeks
Secondary Outcome Measure Information:
Title
Neonatal outcomes
Description
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.
Time Frame
Up to 10 months
Title
Neonatal tertiary outcomes
Description
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.
Time Frame
Up to 10 months
Title
Pregnancy complications
Description
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.
Time Frame
Up to 10 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simin Liu, MD, ScD, MS, MPH
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
200 Medical Plaza UCLA Ob/Gyn Clinic
City
Westwood
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
West Medical UCLA Ob/Gyn Clinic
City
Westwood
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

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

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