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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D | Experimental | Will receive capsules with 5,000 IU of vitamin D3, one capsule orally once a day for eight weeks |
|
| Placebo | Placebo Comparator | Will receive capsules with placebo (talcum food grade) one capsule orally once a day for eight weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 | Dietary Supplement | Capsules with 5,000 IU of vitamin D3 once a day (one capsule) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the parameters that make up the glycemic profile | Glucose, HBA1c, insuline, | Eight weeks |
| 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 |
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Inclusion Criteria: Patients with a single pregnancy.
Exclusion Criteria: Patients with pre-existing diabetes mellitus
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| Name | Affiliation | Role |
|---|---|---|
| Salvador Mora | OPD Hospital Civil de Guadalajara | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eva Elizabet Camarena Pulido | Guadalajara | Jalisco | 44340 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21706518 | Result | 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. | |
| 18771564 | Result | 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. |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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Parallel design, two arms
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The capsules with vitamin D or placebo have the same organoleptic characteristics. The jars and envelopes that contain them are identical. The envelopes are identified by a code that only knows who will analyze the data
| Capsules with placebo (talcum food grade) |
| Other |
Capsules with placebo (talcum food grade) |
|
| 24353500 | Result | 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. |
| 27247730 | Result | 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. |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |