Clinical trial NCT03645109: Effect of Suplementation of Vitamin D in Gestational Diabetes Mellitus
Official title: Effect of Suplementation of 5,000 UI Vitamin D3 on the Glycemic Profile in Patients With Gestational Diabetes Mellitus of the Hospital Civil de Guadalajara Dr. Juan I. Menchaca
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D3
Gestational Diabetes Mellitus in Pregnancy
Lead sponsor: Hospital Civil Juan I. Menchaca
Sponsor class: OTHER
First posted: 2018-08-24
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel design, two arms
Primary purpose: TREATMENT

Brief summary: Randomized double-blind placebo-controlled clinical trial. Consists of the administration of 5,000 IU of vitamin D3 vs Placebo in patients with gestational diabetes mellitus during eight weeks. The objective is to analyze the effects of the intervention on the biochemical parameters that are part of the glycemic profile (insuline, HBA1c, glucose)

Detailed description: Two groups of patients diagnosed with gestational diabetes mellitus. Once the selection criteria are verified, they will be assigned randomly in one of the two arms,one of them will recive 5,000 IU of vitamin D and the other one placebo (talcum food grade). Baseline measurements of vitamin D, glucose,insulin, HBA1c, calcium, phosphorus. At the end of the eight weeks will be determined again the aforementioned biochemical parameters.

Eligibility criteria: Inclusion Criteria: Patients with a single pregnancy.

* Patients diagnosed with GDM, which were diagnosed by a glucose tolerance curve 100 grams of glucose, with two altered results from the following: fasting\> 95 miligrams / deciliter, 1 hour\> 180miligrams / deciliter, 2 hour\> 155miligrams / deciliter, 3hous\> 140 miligrams / deciliter.
* Gestational age between 24 -30 weeks confirmed with ultrasound of the 1st or 2nd trimester
* Age between 18 and 40 years.

Exclusion Criteria: Patients with pre-existing diabetes mellitus

* Patients with predictive factors for vitamin D hypovitaminosis such as: use of anticonvulsants, renal disease, glomerular filtration rate \<60milliliters / minute, thyroid disease or any other pre-existing endocrinological disorders.
* Hypercalciuria\> 300 miligrams / day
* Patients taking vitamin D supplementation during the 6 months prior to the study (does not include polyvitamins with lower vitamin D concentrations \<500 IU)
* Active and passive smoking patients.

Primary outcomes:
measure: Changes in the parameters that make up the glycemic profile
timeFrame: Eight weeks
Secondary outcomes:
measure: Changes in calcium, phosphorus and vitamin D3
timeFrame: Eight weeks
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Eva Elizabet Camarena Pulido
state: Jalisco
Study officials:
affiliation: OPD Hospital Civil de Guadalajara
name: Salvador Mora
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hollis BW, Johnson D, Hulsey TC, Ebeling M, Wagner CL. Vitamin D supplementation during pregnancy: double-blind, randomized clinical trial of safety and effectiveness. J Bone Miner Res. 2011 Oct;26(10):2341-57. doi: 10.1002/jbmr.463.
citation: Yu CK, Sykes L, Sethi M, Teoh TG, Robinson S. Vitamin D deficiency and supplementation during pregnancy. Clin Endocrinol (Oxf). 2009 May;70(5):685-90. doi: 10.1111/j.1365-2265.2008.03403.x. Epub 2008 Sep 2.
citation: Parildar H, Dogruk Unal A, Aksan Desteli G, Cigerli O, Guvener Demirag N. Frequency of Vitamin D deficiency in pregnant diabetics at Baskent University Hospital, Istanbul. Pak J Med Sci. 2013 Jan;29(1):15-20. doi: 10.12669/pjms.291.2896.
citation: Yazdchi R, Gargari BP, Asghari-Jafarabadi M, Sahhaf F. Effects of vitamin D supplementation on metabolic indices and hs-CRP levels in gestational diabetes mellitus patients: a randomized, double-blinded, placebo-controlled clinical trial. Nutr Res Pract. 2016 Jun;10(3):328-35. doi: 10.4162/nrp.2016.10.3.328. Epub 2016 May 16.