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

NCT01510665 | Completed

• 1 other identifier: Magnesium123
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

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.

Conditions

Gestational Diabetes; Obesity

Keywords

Weight gain in pregnancy; Metabolic and Inflammatory markers

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  Up to 10 months

• 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.

  Up to 36 weeks

Secondary Outcomes (3)

• Neonatal outcomes

  Up to 10 months

• Neonatal tertiary outcomes

  Up to 10 months

• Pregnancy complications

  Up to 10 months

Study Arms (3)

Magnesium Supplement

EXPERIMENTAL

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

Dietary Supplement: Magnesium citrate

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Diet

ACTIVE COMPARATOR

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

Behavioral: Dietary modification

Interventions

Magnesium citrate DIETARY_SUPPLEMENT

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

Magnesium Supplement

Placebo DIETARY_SUPPLEMENT

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

Placebo

Dietary modification BEHAVIORAL

Nutritionist counseling session and advice on following a magnesium rich diet

Diet

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (2)

200 Medical Plaza UCLA Ob/Gyn Clinic

Westwood, Los Angeles, California, 90095, United States

Location

West Medical UCLA Ob/Gyn Clinic

Westwood, Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational; Obesity; Gestational Weight Gain

Interventions

magnesium citrate; Diet Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Simin Liu, MD, ScD, MS, MPH

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 23, 2011
• First Posted: January 16, 2012
• Study Start: January 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: June 14, 2013

Record last verified: 2013-06

Locations

US (2)