NCT01634516 - 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)

Sewell DA, Hammersley VS, Devereux G, Robertson A, Stoddart A, Weir C, Worth A, Sheikh A
Investigating the effectiveness of the Mediterranean diet in pregnant women for the primary prevention of asthma and allergy in high-risk infants: protocol for a pilot randomised controlled trial. Trials. 2013 Jun 14;14:173. doi: 10.1186/1745-6215-14-173.
Sewell DA, Hammersley VS, Robertson A, Devereux G, Stoddart A, Weir CJ, Worth A, Sheikh A
A pilot randomised controlled trial investigating a Mediterranean diet intervention in pregnant women for the primary prevention of allergic diseases in infants. J Hum Nutr Diet. 2017 Feb 16. doi: 10.1111/jhn.12469. [Epub ahead of print]

An Investigation of the Effectiveness of the Mediterranean Diet in Pregnant Women at Risk of Developing Allergy in Their Infants: Pilot Randomised Controlled Trial

Details for clinical trial NCT01634516

Clinical trial NCT01634516 - References