Magnesium Supplementation in the Second Trimester of Pregnancy to Overweight and Obese Individuals
NCT ID: NCT01510665
Last Updated: 2013-06-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
28 participants
INTERVENTIONAL
2012-01-31
2013-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Randomized Clinical Trial of Oral Magnesium Supplementation in Pregnancy
NCT02032186
Magnesium Sulfate in Obese Preeclamptics
NCT02835339
PK/PD Modeling of Magnesium in the Mother and Neonate
NCT01709630
Serum Magnesium Level Administration in Severe Pre-eclampsia Obese Pregnancy
NCT03661775
The Effect of Magnesium on Maternal Mood, Cognitive Function, and Birth Experience
NCT02454322
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Magnesium Supplement
Magnesium citrate dietary supplement (300 mg elemental Magnesium daily dose) given week 13 to week 28 (two pills daily)
Magnesium citrate
Magnesium citrate tablets 950 mg, two pills once daily (Total daily dose of 300 mg elemental magnesium)
Placebo
Identical appearing pill with inactive ingredients given week 13 to week 28 (two pills daily)
Placebo
Identical appearing placebo with inactive ingredients, two pills once daily.
Diet
Nutritionist counseling session and advice on following a magnesium rich diet from week 13 to week 28
Dietary modification
Nutritionist counseling session and advice on following a magnesium rich diet
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Magnesium citrate
Magnesium citrate tablets 950 mg, two pills once daily (Total daily dose of 300 mg elemental magnesium)
Placebo
Identical appearing placebo with inactive ingredients, two pills once daily.
Dietary modification
Nutritionist counseling session and advice on following a magnesium rich diet
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Pregnant in the first trimester
* Able to give informed consent
* Planning to deliver at UCLA
* BMI greater than or equal to 25
Exclusion Criteria
* 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
18 Years
40 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of California, Los Angeles
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Simin Liu, Dr.
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Simin Liu, MD, ScD, MS, MPH
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
200 Medical Plaza UCLA Ob/Gyn Clinic
Westwood, Los Angeles, California, United States
West Medical UCLA Ob/Gyn Clinic
Westwood, Los Angeles, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Magnesium123
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.