Effect of Suplementation of Vitamin D in Gestational Diabetes Mellitus

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Vitamin D3, Gestational Diabetes Mellitus in Pregnancy

Intervention / Treatment
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* Dietary Supplement: Vitamin D3
* Other: Capsules with placebo (talcum food grade)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel design, two arms
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D<br>Will receive capsules with 5,000 IU of vitamin D3, one capsule orally once a day for eight weeks | Dietary Supplement: Vitamin D3<br>* Capsules with 5,000 IU of vitamin D3 once a day (one capsule)<br>|
| Placebo Comparator: Placebo<br>Will receive capsules with placebo (talcum food grade) one capsule orally once a day for eight weeks | Other: Capsules with placebo (talcum food grade)<br>* Capsules with placebo (talcum food grade)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the parameters that make up the glycemic profile | Glucose, HBA1c, insuline, | Eight weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in calcium, phosphorus and vitamin D3 | Concentrations of calcium and phosphorus in blood and urine and vitamin D in blood | Eight weeks |