NCT01365975 - 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)

Bailey LB, Gregory JF 3rd
Folate metabolism and requirements. J Nutr. 1999 Apr;129(4):779-82. Review.
Laurence KM, James N, Miller MH, Tennant GB, Campbell H
Double-blind randomised controlled trial of folate treatment before conception to prevent recurrence of neural-tube defects. Br Med J (Clin Res Ed). 1981 May 9;282(6275):1509-11.
Smithells RW, Nevin NC, Seller MJ, Sheppard S, Harris R, Read AP, Fielding DW, Walker S, Schorah CJ, Wild J
Further experience of vitamin supplementation for prevention of neural tube defect recurrences. Lancet. 1983 May 7;1(8332):1027-31.

Follow-up Study of Late Effects of Periconceptional Folic Acid in Mothers and Offspring in the Community Intervention Program Population: The Chinese Children and Families Study

Details for clinical trial NCT01365975

Clinical trial NCT01365975 - References