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NCT01510665 · ClinicalTrials.gov registry record · NA
Magnesium Supplementation in the Second Trimester of Pregnancy to Overweight and Obese Individuals
A NA study of Obesity and Gestational Diabetes, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- NA
- Development phase
- 28
- Enrollment target
- 2
- Study locations
NCT01510665 is a NA study of Obesity and Gestational Diabetes that has completed, run by University of California, Los Angeles. The registered enrollment target is 28 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (97% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT01510665, a NA study of Obesity and Gestational Diabetes, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- NA
- Development phase
- 28 participants
- Enrollment target
- 2
- Study locations
Study 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 Studied
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT Magnesium citrate
- BEHAVIORAL Dietary modification
Study Locations (2)
California
- 200 Medical Plaza UCLA Ob/Gyn Clinic - Westwood, Los Angeles
- West Medical UCLA Ob/Gyn Clinic - Westwood, Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2012-01 |
| Est. Completion | 2013-06 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01510665
The ClinicalTrials.gov registry entry for NCT01510665 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (97% lower). The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01510665 reports 2 study locations spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT01510665 about?
NCT01510665 is a clinical study titled "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 ...
What is the current status of trial NCT01510665?
This trial is currently completed. It is a NA study. The enrollment target is 28 participants. The study started on 2012-01. Estimated completion is 2013-06.
What conditions does trial NCT01510665 study?
This clinical trial studies the following conditions: Obesity, Gestational Diabetes.
What interventions are being tested in trial NCT01510665?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Magnesium citrate (DIETARY_SUPPLEMENT), Dietary modification (BEHAVIORAL).
Who is sponsoring clinical trial NCT01510665?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01510665 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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