Gestational DiabetesNCT01510665
Magnesium Supplementation in the Second Trimester of Pregnancy to Overweight and Obese Individuals
A study testing Magnesium citrate and Dietary modification in people with Gestational Diabetes and Obesity, run by University of California, Los Angeles at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes, Obesity
- What is being tested?
- Magnesium citrate and Dietary modification
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2012to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
200 Medical Plaza UCLA Ob/Gyn Clinic
Westwood, Los Angeles, California, 90095
West Medical UCLA Ob/Gyn Clinic
Westwood, Los Angeles, California, 90095
About this study
Official title: Magnesium Supplementation in the Second Trimester of Pregnancy for Overweight 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 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
- Being tested
- Magnesium citrate, Placebo, Dietary modification
- Keywords
- Weight gain in pregnancy, Metabolic and Inflammatory markers
- Medical subject headings
- Diabetes, Gestational, Obesity, Gestational Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium citrateDietary supplement
Magnesium citrate tablets 950 mg, two pills once daily (Total daily dose of 300 mg elemental magnesium)
PlaceboDietary supplement
Identical appearing placebo with inactive ingredients, two pills once daily.
Dietary modificationBehavioural
Nutritionist counseling session and advice on following a magnesium rich diet
| Study group | Role | What they receive |
|---|---|---|
| Magnesium Supplement | Experimental | Magnesium citrate dietary supplement (300 mg elemental Magnesium daily dose) given week 13 to week 28 (two pills daily) Receives: Dietary Supplement: Magnesium citrate |
| Placebo | Placebo comparator | Identical appearing pill with inactive ingredients given week 13 to week 28 (two pills daily) Receives: Dietary Supplement: Placebo |
| Diet | Active comparator | Nutritionist counseling session and advice on following a magnesium rich diet from week 13 to week 28 Receives: Behavioral: Dietary modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to 36 weeks
Secondary outcomes (3)
Neonatal outcomes
This measure will be assessed at neonatal delivery, which will occur at a maximum of up to 10 months from randomization. At delivery, neonatal characteristics will be assessed:
Macrosomia, preterm birth, head circumference, and apgar score.
Measured: Up to 10 months
Neonatal tertiary outcomes
This measure will be assessed at neonatal delivery, which will occur at a maximum of up to 10 months from randomization. Cord blood and placenta will be collected at delivery, and we will examine endothelial progenitor cell presence in cord blood, PON expression in cord blood, and DNA expression from the placental tissue.
Measured: Up to 10 months
Pregnancy complications
From date of randomization until the date of delivery of the neonate, up to a maximum of 10 months, pregnancy complications such as development of gestational diabetes, hypertension, proteinuria, shoulder dystocia, cesarean section, as well as amount of weight gain will be assessed from the chart.
Measured: Up to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simin Liu, Dr., University of California, Los Angeles
- Investigators
- Simin Liu, MD, ScD, MS, MPH, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01510665
- Sponsor's protocol ID
- Magnesium123
- Status last verified
- Jun 2013
- First submitted
- 23 Dec 2011
- Last updated
- 14 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnesium Supplementation in the Second Trimester of Pregnancy for Overweight Individuals
- ClinicalTrials.gov ID
- NCT01510665
- Acronym / sponsor ID
- Magnesium123
- Conditions
- Gestational Diabetes, Obesity
- Keywords
- Weight gain in pregnancy, Metabolic and Inflammatory markers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 16 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Magnesium Supplement | Experimental | Dietary Supplement: Magnesium citrateMagnesium citrate dietary supplement (300 mg elemental Magnesium daily dose) given week 13 to week 28 (two pills daily) |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboIdentical appearing pill with inactive ingredients given week 13 to week 28 (two pills daily) |
| Diet | Active comparator | Behavioral: Dietary modificationNutritionist counseling session and advice on following a magnesium rich diet from week 13 to week 28 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium citrateMagnesium citrate tablets 950 mg, two pills once daily (Total daily dose of 300 mg elemental magnesium) | Dietary supplement | Magnesium Supplement |
| PlaceboIdentical appearing placebo with inactive ingredients, two pills once daily. | Dietary supplement | Placebo |
| Dietary modificationNutritionist counseling session and advice on following a magnesium rich diet | Behavioural | Diet |
Primary outcome
Change in maternal biomarkers during pregnancy up to 28 weeks
Time frame: 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.
Neonatal birth weight/height
Time frame: Up to 10 months
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.
Change in maternal biomarkers in pregnancy in the third trimester
Time frame: Up to 36 weeks
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.
3 secondary outcomes
Neonatal outcomes
Time frame: Up to 10 months
Neonatal tertiary outcomes
Time frame: Up to 10 months
Pregnancy complications
Time frame: Up to 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simin Liu, MD, ScD, MS, MPH principal investigator
University of California, Los Angeles
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium citrate and Dietary modification in people with Gestational Diabetes and Obesity, run by University of California, Los Angeles at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in maternal biomarkers during pregnancy up to 28 weeks (time frame: up to 28 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2013.