NCT03645109 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

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
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.
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.
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.

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

Details for clinical trial NCT03645109

Clinical trial NCT03645109 - References