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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: Completed NA study of Obesity and Gestational Diabetes, sponsored by University of California, Los Angeles.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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 |
What the finished NCT01510665 record still lists
NCT01510665 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (97% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT01510665's enrollment target sits among peer trials
28 886th of 1053 higher than 162 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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