Status:
COMPLETED
A Randomized Controlled Trial Testing The Effect Of A Multi-Nutrient Fortified Juice
Lead Sponsor:
Boston University
Conditions:
Vitamin D Deficiency
Hypovitaminosis A
Eligibility:
All Genders
6-10 years
Phase:
NA
Brief Summary
The goal of this investigator-initiated study is to determine whether the fortification of orange juice with vitamin D, vitamin A, and vitamin E will enhance the vitamin D, vitamin A, and vitamin E st...
Detailed Description
This is an investigator-initiated double-blinded study in which one hundred and eighty male and female subjects ages 6 to 10 will be recruited from the Division of Pediatrics at Boston University Medi...
Eligibility Criteria
Inclusion
- 1\. Male and female children of all races with ages between 6 and 10
Exclusion
- History of rickets
- History of intestinal malabsorption (i.e. Cystic Fibrosis, Fat Malabsorption Syndrome, Crohn's Disease)
- History of severe medical illness, including renal failure (decrease 2/3 kidney function)
- Allergies to orange juice
- Any medical conditions in which it is not advisable to receive two 8 oz. glasses of orange juice per day
- History of Diabetes
- Currently taking, or having taken less than one month prior to start of study, a prescription vitamin D
- Unwilling to consent/assent to this trial
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT01909063
Start Date
January 1 2005
End Date
January 1 2008
Last Update
February 28 2017
Active Locations (1)
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1
Boston Medical Center
Boston, Massachusetts, United States, 02118