Effect of Suplementation of Vitamin D in Gestational Diabetes Mellitus

Gestational Diabetes Mellitus in Pregnancy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03645109
• Other study ID #: 0240/18HCJIM/18
• Status: Completed
• Phase: N/A
• Start date: February 28, 2020
• Est. completion date: March 10, 2020

Study information

• Verified date: March 2021
• Source: Hospital Civil Juan I. Menchaca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 10, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus in Pregnancy
• Pregnancy in Diabetics
• Vitamin D3

Intervention

Dietary Supplement:
• Vitamin D3
Capsules with 5,000 IU of vitamin D3 once a day (one capsule)

Other:
• Capsules with placebo (talcum food grade)
Capsules with placebo (talcum food grade)

Locations

Country	Name	City	State
Mexico	Eva Elizabet Camarena Pulido	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Eva Elizabet Camarena Pulido

Country where clinical trial is conducted

Mexico, 

References & Publications (4)

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. Erratum in: J Bone Mi — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the parameters that make up the glycemic profile	Glucose, HBA1c, insuline,	Eight weeks
Secondary	Changes in calcium, phosphorus and vitamin D3	Concentrations of calcium and phosphorus in blood and urine and vitamin D in blood	Eight weeks