NCT01050387 - 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)

DeLucia MC, Mitnick ME, Carpenter TO
Nutritional rickets with normal circulating 25-hydroxyvitamin D: a call for reexamining the role of dietary calcium intake in North American infants. J Clin Endocrinol Metab. 2003 Aug;88(8):3539-45.
Gungor N, Saad R, Janosky J, Arslanian S
Validation of surrogate estimates of insulin sensitivity and insulin secretion in children and adolescents. J Pediatr. 2004 Jan;144(1):47-55.
Heaney RP, Davies KM, Chen TC, Holick MF, Barger-Lux MJ
Human serum 25-hydroxycholecalciferol response to extended oral dosing with cholecalciferol. Am J Clin Nutr. 2003 Jan;77(1):204-10. Erratum in: Am J Clin Nutr. 2003 Nov;78(5):1047.
Pettifor JM
Nutritional Rickets. In: Pediatric Bone: Biology and Diseases. Glorieux FH, Pettifor JM, Juppner H (eds.) Academic Press: San Diego, CA, p 541-565, 2003.
Safadi FF, Thornton P, Magiera H, Hollis BW, Gentile M, Haddad JG, Liebhaber SA, Cooke NE
Osteopathy and resistance to vitamin D toxicity in mice null for vitamin D binding protein. J Clin Invest. 1999 Jan;103(2):239-51.
Zella LA, Shevde NK, Hollis BW, Cooke NE, Pike JW
Vitamin D-binding protein influences total circulating levels of 1,25-dihydroxyvitamin D3 but does not directly modulate the bioactive levels of the hormone in vivo. Endocrinology. 2008 Jul;149(7):3656-67. doi: 10.1210/en.2008-0042. Epub 2008 Mar 27.

A Randomized, Controlled Trial of Vitamin D Supplementation in Infants and Children: Effects of Vitamin D Dose and Genotype of the Binding Protein

Clinical trial NCT01050387 - References