Magnesium Lactate in the Reduction of Gestational Diabetes Incidence.
NCT ID: NCT04037098
Last Updated: 2023-09-28
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
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WITHDRAWN
NA
INTERVENTIONAL
2022-07-31
2023-09-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
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.
PREVENTION
DOUBLE
Study Groups
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Magnesium
Magnesium lactate, 2 tablets orally every 12 hours (equivalent to 360 mg of elemental magnesium) for 3 months plus baseline dietary magnesium requirement.
Magnesium lactate.
2 tablets orally every 12 hours (equivalent to 360 mg of elemental magnesium) for 3 months
Control
2 tablets orally every 12 hours of on inert placebo for three months plus baseline dietary magnesium requirement.
Placebo
2 tablets orally every 12 hours of on inert placebo for three months
Interventions
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Magnesium lactate.
2 tablets orally every 12 hours (equivalent to 360 mg of elemental magnesium) for 3 months
Placebo
2 tablets orally every 12 hours of on inert placebo for three months
Eligibility Criteria
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Inclusion Criteria
* 12th to 14th gestation weeks.
* Informed consent of the participant.
Exclusion Criteria
* High blood pressure.
* Hypertriglyceridemia (\>250 g/dL)
* Neoplasia disease.
* Thyroid disease.
* Hepatic disease.
* 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)
19 Years
35 Years
FEMALE
Yes
Sponsors
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Coordinación de Investigación en Salud, Mexico
OTHER_GOV
Responsible Party
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Fernando Guerrero Romero MD
Head of the research unit
Principal Investigators
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Fernando PD Guerrero
Role: PRINCIPAL_INVESTIGATOR
Instituto Mexicano del Seguro Social
Luis PD Simental
Role: STUDY_CHAIR
Instituto Mexicano del Seguro Social
Gerardo PD Martínez
Role: STUDY_CHAIR
Instituto Mexicano del Seguro Social
Cludia PD Gamboa
Role: STUDY_CHAIR
Instituto Mexicano del Seguro Social
Locations
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Biomedical Research Unit. IMSS. Durango
Durango, Durango, Mexico
Countries
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References
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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.
Kim C. Maternal outcomes and follow-up after gestational diabetes mellitus. Diabet Med. 2014 Mar;31(3):292-301. doi: 10.1111/dme.12382.
Al-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.
Fan 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.
Sarrafzadegan 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.
Asemi 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.
Han 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.
Dalton 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.
Makrides 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.
Guerrero-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.
Morton A. Hypomagnesaemia and pregnancy. Obstet Med. 2018 Jun;11(2):67-72. doi: 10.1177/1753495X17744478. Epub 2018 Mar 7.
Alves 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.
Dainelli 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.
Ramirez-Torres MA. The importance of gestational diabetes beyond pregnancy. Nutr Rev. 2013 Oct;71 Suppl 1:S37-41. doi: 10.1111/nure.12070.
Other Identifiers
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R-2019-785-040
Identifier Type: -
Identifier Source: org_study_id
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