Pregnancy RelatedNCT04037098
Magnesium Lactate in the Reduction of Gestational Diabetes Incidence.
A study testing Magnesium lactate. in people with Pregnancy Related, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
Trial summary
Gestational diabetes, occurs during the second or third trimester of pregnancy, with no prior history of diabetes; this entity can be resolved at the end of pregnancy. Magnesium is the fourth most abundant mineral in the body, It plays an essential role in the regulation of insulin metabolism, in the functions of… Read more about this study
- Who is it for?
- Ages 19 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Magnesium lactate.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteMexico
- Study dates
- 31 Jul 2022to Sep 2023
- 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 19 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women aged 19 to 35 years.
- 12th to 14th gestation weeks.
- Informed consent of the participant.
Who cannot join
- Diabetes.
- High blood pressure.
- Hypertriglyceridemia (>250 g/dL)
- Neoplasia disease.
- Thyroid disease.
- Hepatic disease.
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- Consumption of alcoholic beverages.
- Smoking.
- Medication use (thiazide diuretics, anti-blocking agents, calcium antagonists, statins, nicotinic acid, phenytoin, valproic acid, antidepressants, beta-adrenergic, theophylline, glucocorticoids, in the last year)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficiency and Safety of Magnesium Lactate Administration in the Reduction of Gestational Diabetes Incidence.
Gestational diabetes, occurs during the second or third trimester of pregnancy, with no prior history of diabetes; this entity can be resolved at the end of pregnancy. Magnesium is the fourth most abundant mineral in the body, It plays an essential role in the regulation of insulin metabolism, in the functions of adenosine triphosphate. In Mexico, the prevalence of hypomagnesemia is 36.3% for women. Findings suggesting that magnesium supplementation may be a beneficial indication in metabolic glucose disorders. The hypothesis of this study is: that Magnesium lactate administration is safe and reduces the incidence of gestational diabetes.
Read the detailed description
Objective: This study aims to evaluate the efficacy and safety of magnesium lactate oral administration in reducing the gestational diabetes incidence.
Design: Randomized, double-blind, placebo-controlled clinical trial.
Study population: Pregnant women aged 19 to 35 years, in the twelfth week of pregnancy, whit hypomagnesemia and without the concomitant disease.
Study groups: an intervention group and a control group.
Sample size: It was calculated using a statistical power of 80%, an alpha value of 0.05; 15% of the difference in the mean of gestational diabetes incidence control group and intervention groups was considered. The estimated sample size was 110 subjects for each group.
Process: All eligible participants according to inclusion and exclusion criteria, will be randomized to one of the study groups.
The intervention group will receive magnesium lactate, 2 tablets orally every 12 hours (equivalent to 360 mg of elemental magnesium) for 3 months plus baseline dietary magnesium requirement; the control group will receive 2 tablets orally every 12 hours of on inert placebo for three months plus baseline dietary magnesium requirement.
The blood concentrations of glucose, triglycerides, magnesium, creatinine, transaminases, and thyroid hormones will be measured, as well as the anthropometric measurements, at baseline and end conditions. Also, an oral glucose tolerance curve will be realized at the 20th gestation week.
Statistical analysis: Numerical values will be expressed as mean ± standard deviation; categorical variables will be expressed as proportions. Differences between the groups were estimated by unpaired Student t-test for numerical variables (Mann-Whitney U test for skewed data) or Chi-square and Fisher´s exact test for categorical variables. Intragroup differences were estimated by paired Student t-test.
- Conditions
- Pregnancy Related
- Being tested
- Magnesium lactate., Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium lactate.Dietary supplement
2 tablets orally every 12 hours (equivalent to 360 mg of elemental magnesium) for 3 months
PlaceboDietary supplement
2 tablets orally every 12 hours of on inert placebo for three months
| Study group | Role | What they receive |
|---|---|---|
| Magnesium | Experimental | Magnesium lactate, 2 tablets orally every 12 hours (equivalent to 360 mg of elemental magnesium) for 3 months plus baseline dietary magnesium requirement. Receives: Dietary Supplement: Magnesium lactate. |
| Control | Placebo comparator | 2 tablets orally every 12 hours of on inert placebo for three months plus baseline dietary magnesium requirement. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased of gestational diabetes incidence
The incidence of gestational diabetes will be considered as a decrease, at the small proportion difference of less than 13.4% between the incidence of gestational diabetes in the intervention group and the placebo group.
Measured: Three months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start31 Jul 2022
- Primary completion31 Jul 2022
- Study completionSep 2023 (estimated)
Why it stopped: Lack of financial support and pandemia
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study groups: Intervention group. Women 19 to 35 years of age, in the twelfth week of pregnancy, who will receive magnesium lactate, 2 tablets orally every 12 hours (equivalent to 360 mg of elemental magnesium) for 3 months plus baseline dietary magnesium requirement. Control group. Women 19 to 35 years of age, in the twelfth week of pregnancy, who will receive 2 tablets orally every 12 hours of on inert placebo for three months plus baseline dietary magnesium requirement.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fernando Guerrero Romero MD, Coordinación de Investigación en Salud, Mexico
- Investigators
- Fernando PD Guerrero, Principal investigator, Instituto Mexicano del Seguro SocialLuis PD Simental, Study chair, Instituto Mexicano del Seguro SocialGerardo PD Martínez, Study chair, Instituto Mexicano del Seguro SocialCludia PD Gamboa, Study chair, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04037098
- Sponsor's protocol ID
- R-2019-785-040
- Status last verified
- Sep 2023
- First submitted
- 26 Jul 2019
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mack LR, Tomich PG. Gestational Diabetes: Diagnosis, Classification, and Clinical Care. Obstet Gynecol Clin North Am. 2017 Jun;44(2):207-217. doi: 10.1016/j.ogc.2017.02.002.
PubMed 28499531Kim C. Maternal outcomes and follow-up after gestational diabetes mellitus. Diabet Med. 2014 Mar;31(3):292-301. doi: 10.1111/dme.12382.
PubMed 24341443Al-Badri MR, Zantout MS, Azar ST. The role of adipokines in gestational diabetes mellitus. Ther Adv Endocrinol Metab. 2015 Jun;6(3):103-8. doi: 10.1177/2042018815577039.
PubMed 26137214Fan Y, Xu R, Cai L, Cai L. [Risk factors of gestational diabetes mellitus among the re-birth pregnant women in Xiamen City in 2015-2016]. Wei Sheng Yan Jiu. 2017 Nov;46(6):925-929. Chinese.
PubMed 29903201Sarrafzadegan N, Khosravi-Boroujeni H, Lotfizadeh M, Pourmogaddas A, Salehi-Abargouei A. Magnesium status and the metabolic syndrome: A systematic review and meta-analysis. Nutrition. 2016 Apr;32(4):409-17. doi: 10.1016/j.nut.2015.09.014. Epub 2015 Oct 23.
PubMed 26919891Asemi Z, Karamali M, Jamilian M, Foroozanfard F, Bahmani F, Heidarzadeh Z, Benisi-Kohansal S, Surkan PJ, Esmaillzadeh A. Retracted: Magnesium supplementation affects metabolic status and pregnancy outcomes in gestational diabetes: a randomized, double-blind, placebo-controlled trial. Am J Clin Nutr. 2015 Jul;102(1):222-9. doi: 10.3945/ajcn.114.098616. Epub 2015 May 27.
PubMed 26016859Han H, Fang X, Wei X, Liu Y, Jin Z, Chen Q, Fan Z, Aaseth J, Hiyoshi A, He J, Cao Y. Dose-response relationship between dietary magnesium intake, serum magnesium concentration and risk of hypertension: a systematic review and meta-analysis of prospective cohort studies. Nutr J. 2017 May 5;16(1):26. doi: 10.1186/s12937-017-0247-4.
PubMed 28476161Dalton LM, Ni Fhloinn DM, Gaydadzhieva GT, Mazurkiewicz OM, Leeson H, Wright CP. Magnesium in pregnancy. Nutr Rev. 2016 Sep;74(9):549-57. doi: 10.1093/nutrit/nuw018. Epub 2016 Jul 21.
PubMed 27445320Makrides M, Crosby DD, Bain E, Crowther CA. Magnesium supplementation in pregnancy. Cochrane Database Syst Rev. 2014 Apr 3;2014(4):CD000937. doi: 10.1002/14651858.CD000937.pub2.
PubMed 24696187Guerrero-Romero F, Rodriguez-Moran M. [Oral magnesium supplementation: an adjuvant alternative to facing the worldwide challenge of type 2 diabetes?]. Cir Cir. 2014 May-Jun;82(3):282-9. Spanish.
PubMed 25238470Morton A. Hypomagnesaemia and pregnancy. Obstet Med. 2018 Jun;11(2):67-72. doi: 10.1177/1753495X17744478. Epub 2018 Mar 7.
PubMed 29997688Alves JG, de Araujo CA, Pontes IE, Guimaraes AC, Ray JG. The BRAzil MAGnesium (BRAMAG) trial: a randomized clinical trial of oral magnesium supplementation in pregnancy for the prevention of preterm birth and perinatal and maternal morbidity. BMC Pregnancy Childbirth. 2014 Jul 8;14:222. doi: 10.1186/1471-2393-14-222.
PubMed 25005784Dainelli L, Prieto-Patron A, Silva-Zolezzi I, Sosa-Rubi SG, Espino Y Sosa S, Reyes-Munoz E, Lopez-Ridaura R, Detzel P. Screening and management of gestational diabetes in Mexico: results from a survey of multilocation, multi-health care institution practitioners. Diabetes Metab Syndr Obes. 2018 Apr 5;11:105-116. doi: 10.2147/DMSO.S160658. eCollection 2018.
PubMed 29670384Ramirez-Torres MA. The importance of gestational diabetes beyond pregnancy. Nutr Rev. 2013 Oct;71 Suppl 1:S37-41. doi: 10.1111/nure.12070.
PubMed 24147923
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency and Safety of Magnesium Lactate Administration in the Reduction of Gestational Diabetes Incidence.
- ClinicalTrials.gov ID
- NCT04037098
- Acronym / sponsor ID
- R-2019-785-040
- Conditions
- Pregnancy Related
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of financial support and pandemia
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Study start
- 31 Jul 2022 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- Sep 2023 (estimated)
- First posted
- 30 Jul 2019 (actual)
- 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.
Gestational diabetes, occurs during the second or third trimester of pregnancy, with no prior history of diabetes; this entity can be resolved at the end of pregnancy. Magnesium is the fourth most abundant mineral in the body, It plays an essential role in the regulation of insulin metabolism, in the functions of adenosine triphosphate. In Mexico, the prevalence of hypomagnesemia is 36.3% for women. Findings suggesting that magnesium supplementation may be a beneficial indication in metabolic glucose disorders. The hypothesis of this study is: that Magnesium lactate administration is safe and reduces the incidence of gestational diabetes.
Detailed description
Objective: This study aims to evaluate the efficacy and safety of magnesium lactate oral administration in reducing the gestational diabetes incidence.
Design: Randomized, double-blind, placebo-controlled clinical trial.
Study population: Pregnant women aged 19 to 35 years, in the twelfth week of pregnancy, whit hypomagnesemia and without the concomitant disease.
Study groups: an intervention group and a control group.
Sample size: It was calculated using a statistical power of 80%, an alpha value of 0.05; 15% of the difference in the mean of gestational diabetes incidence control group and intervention groups was considered. The estimated sample size was 110 subjects for each group.
Process: All eligible participants according to inclusion and exclusion criteria, will be randomized to one of the study groups.
The intervention group will receive magnesium lactate, 2 tablets orally every 12 hours (equivalent to 360 mg of elemental magnesium) for 3 months plus baseline dietary magnesium requirement; the control group will receive 2 tablets orally every 12 hours of on inert placebo for three months plus baseline dietary magnesium requirement.
The blood concentrations of glucose, triglycerides, magnesium, creatinine, transaminases, and thyroid hormones will be measured, as well as the anthropometric measurements, at baseline and end conditions. Also, an oral glucose tolerance curve will be realized at the 20th gestation week.
Statistical analysis: Numerical values will be expressed as mean ± standard deviation; categorical variables will be expressed as proportions. Differences between the groups were estimated by unpaired Student t-test for numerical variables (Mann-Whitney U test for skewed data) or Chi-square and Fisher´s exact test for categorical variables. Intragroup differences were estimated by paired Student t-test.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Study groups: Intervention group. Women 19 to 35 years of age, in the twelfth week of pregnancy, who will receive magnesium lactate, 2 tablets orally every 12 hours (equivalent to 360 mg of elemental magnesium) for 3 months plus baseline dietary magnesium requirement. Control group. Women 19 to 35 years of age, in the twelfth week of pregnancy, who will receive 2 tablets orally every 12 hours of on inert placebo for three months plus baseline dietary magnesium requirement.
| Arm | Type | Receives |
|---|---|---|
| Magnesium | Experimental | Dietary Supplement: Magnesium lactate.Magnesium lactate, 2 tablets orally every 12 hours (equivalent to 360 mg of elemental magnesium) for 3 months plus baseline dietary magnesium requirement. |
| Control | Placebo comparator | Dietary Supplement: Placebo2 tablets orally every 12 hours of on inert placebo for three months plus baseline dietary magnesium requirement. |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant women aged 19 to 35 years.
- 12th to 14th gestation weeks.
- Informed consent of the participant.
Key exclusion criteria (9 listed)
- Diabetes.
- High blood pressure.
- Hypertriglyceridemia (>250 g/dL)
- Neoplasia disease.
- Thyroid disease.
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 lactate.2 tablets orally every 12 hours (equivalent to 360 mg of elemental magnesium) for 3 months | Dietary supplement | Magnesium |
| Placebo2 tablets orally every 12 hours of on inert placebo for three months | Dietary supplement | Control |
Primary outcome
Decreased of gestational diabetes incidence
Time frame: Three months.
The incidence of gestational diabetes will be considered as a decrease, at the small proportion difference of less than 13.4% between the incidence of gestational diabetes in the intervention group and the placebo group.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Background: PubMed 28499531Mack LR, Tomich PG. Gestational Diabetes: Diagnosis, Classification, and Clinical Care. Obstet Gynecol Clin North Am. 2017 Jun;44(2):207-217. doi: 10.1016/j.ogc.2017.02.002.
- Background: PubMed 24341443Kim C. Maternal outcomes and follow-up after gestational diabetes mellitus. Diabet Med. 2014 Mar;31(3):292-301. doi: 10.1111/dme.12382.
- Background: PubMed 26137214Al-Badri MR, Zantout MS, Azar ST. The role of adipokines in gestational diabetes mellitus. Ther Adv Endocrinol Metab. 2015 Jun;6(3):103-8. doi: 10.1177/2042018815577039.
- Background: PubMed 29903201Fan Y, Xu R, Cai L, Cai L. [Risk factors of gestational diabetes mellitus among the re-birth pregnant women in Xiamen City in 2015-2016]. Wei Sheng Yan Jiu. 2017 Nov;46(6):925-929. Chinese.
- Background: PubMed 26919891Sarrafzadegan N, Khosravi-Boroujeni H, Lotfizadeh M, Pourmogaddas A, Salehi-Abargouei A. Magnesium status and the metabolic syndrome: A systematic review and meta-analysis. Nutrition. 2016 Apr;32(4):409-17. doi: 10.1016/j.nut.2015.09.014. Epub 2015 Oct 23.
- Background: PubMed 26016859Asemi Z, Karamali M, Jamilian M, Foroozanfard F, Bahmani F, Heidarzadeh Z, Benisi-Kohansal S, Surkan PJ, Esmaillzadeh A. Retracted: Magnesium supplementation affects metabolic status and pregnancy outcomes in gestational diabetes: a randomized, double-blind, placebo-controlled trial. Am J Clin Nutr. 2015 Jul;102(1):222-9. doi: 10.3945/ajcn.114.098616. Epub 2015 May 27.
- Background: PubMed 28476161Han H, Fang X, Wei X, Liu Y, Jin Z, Chen Q, Fan Z, Aaseth J, Hiyoshi A, He J, Cao Y. Dose-response relationship between dietary magnesium intake, serum magnesium concentration and risk of hypertension: a systematic review and meta-analysis of prospective cohort studies. Nutr J. 2017 May 5;16(1):26. doi: 10.1186/s12937-017-0247-4.
- Background: PubMed 27445320Dalton LM, Ni Fhloinn DM, Gaydadzhieva GT, Mazurkiewicz OM, Leeson H, Wright CP. Magnesium in pregnancy. Nutr Rev. 2016 Sep;74(9):549-57. doi: 10.1093/nutrit/nuw018. Epub 2016 Jul 21.
- Background: PubMed 24696187Makrides M, Crosby DD, Bain E, Crowther CA. Magnesium supplementation in pregnancy. Cochrane Database Syst Rev. 2014 Apr 3;2014(4):CD000937. doi: 10.1002/14651858.CD000937.pub2.
- Background: PubMed 25238470Guerrero-Romero F, Rodriguez-Moran M. [Oral magnesium supplementation: an adjuvant alternative to facing the worldwide challenge of type 2 diabetes?]. Cir Cir. 2014 May-Jun;82(3):282-9. Spanish.
- Background: PubMed 29997688Morton A. Hypomagnesaemia and pregnancy. Obstet Med. 2018 Jun;11(2):67-72. doi: 10.1177/1753495X17744478. Epub 2018 Mar 7.
- Background: PubMed 25005784Alves JG, de Araujo CA, Pontes IE, Guimaraes AC, Ray JG. The BRAzil MAGnesium (BRAMAG) trial: a randomized clinical trial of oral magnesium supplementation in pregnancy for the prevention of preterm birth and perinatal and maternal morbidity. BMC Pregnancy Childbirth. 2014 Jul 8;14:222. doi: 10.1186/1471-2393-14-222.
- Individual participant dataSharing planned: No
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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.
Fernando PD Guerrero principal investigator
Instituto Mexicano del Seguro Social
Luis PD Simental study chair
Instituto Mexicano del Seguro Social
Gerardo PD Martínez study chair
Instituto Mexicano del Seguro Social
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium lactate. in people with Pregnancy Related, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
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 3 inclusion and 9 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: withdrawn, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. 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 was withdrawn before enrolling participants, so there are no results.
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?
Decreased of gestational diabetes incidence (time frame: Three months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04037098, which also lists 14 linked publications.
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 28 Sep 2023.