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

University of California, Los Angeles (UCLA)

Status: Completed

Conditions: Gestational Diabetes; Obesity

Treatments: Behavioral: Dietary modification; Dietary Supplement: Magnesium citrate; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01510665

Magnesium123

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

28 participants in 3 patient groups, including a placebo group

Magnesium Supplement

Experimental group

Description:

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

Treatment:

Dietary Supplement: Magnesium citrate

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo

Diet

Active Comparator group

Description:

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

Treatment:

Behavioral: Dietary modification