High vs. Low Calcium Intake in the Presence of High Vitamin D: Effect on Gene Expression in the Colon
Study subjects participate for about 3 months. During this time, there is one outpatient
visit, a 4 week inpatient period, a 4 week outpatient period known as a wash out period and
finally another 4 week inpatient period. During the inpatient periods, the Rockefeller
University Hospital (RUH) becomes your home. The subject must sleep here every night and
consume all the food provided. During the screening visit, blood and urine samples will be
taken and an EKG (electrocardiogram) and a complete physical exam will be done. After
enrollment into the study, the first 4 week inpatient period begins. You may continue to go
to work or do other activities as long as you eat the diet provided and sleep at the
Rockefeller University Hospital. You must eat everything that we give you and you may not
substitute or supplement the diet in any way. During each 4 week stay at the Rockefeller
University Hospital, there will be three flexible sigmoidoscopies done and biopsies taken of
the mucosal lining of the colorectum. This procedure is painless and takes about 5 minutes.
In addition, blood samples will be taken every few days for follow-up and research, and two
24 hour urine samples will be done on separate days during the hospitalization. Vital signs
are measured every day and your weight will be measured three times per week. During the
four week wash out period, the subject will return to their home, go about their normal
activities and consume their normal diet. The subject will return to the Rockefeller
University Hospital for the second 4 week inpatient period. The procedures and laboratory
tests are the same during the second inpatient period. The study concludes with the
subjects' discharge from the RUH.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Gene expression related to proliferation, apoptosis, and differentiation of human rectal mucosal cells
end of study
No
Peter Holt, MD
Principal Investigator
Rockefeller University
United States: Institutional Review Board
RUH IRB # PHO-0554
NCT00298545
November 2005
May 2009
Name | Location |
---|---|
Rockefeller University Hospital | New York, New York 10021-6399 |