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NCT01909063 · ClinicalTrials.gov registry record · NA
A Randomized Controlled Trial Testing The Effect Of A Multi-Nutrient Fortified Juice
A NA study, sponsored by Boston University.
- Completed
- Registry status
- NA
- Development phase
- 180
- Enrollment target
NCT01909063 is a NA study that has completed, run by Boston University. The registered enrollment target is 180 participants.
The verdict
NCT01909063, a NA study, has completed, sponsored by Boston University.
- COMPLETED
- Registry status
- NA
- Development phase
- 180 participants
- Enrollment target
Study 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 status children ages 6-10 that are seen at the Division of Pediatrics at Boston University Medical Center. Circulating concentrations of 25-hydroxyvitamin D \[25(OH)D\], vitamin A, and vitamin E before, will be measured at mid-intervention (week 6), and after a period of twelve weeks. This study plans to recruit 180 male and female subjects between the ages of 6 and 10. An informed consent will be explained and discussed with the subjects and their parents/guardians willing to participate in the study. The study will be twelve weeks. Blood will be drawn during the initial visit, mid-intervention (week 6), and week 12. Dietary intake will be assessed at baseline and at the conclusion of the 12-week intervention using a 3-day food record. The subjects will be randomized in a double-blinded manner via an electronically shuffled listed. Subjects will be randomized to receive one of three beverages: (1) calcium plus vitamin D fortified orange juice (intervention A), (2) calcium plus vitamins D, A, and E fortified orange juice (intervention B) or (3) calcium-only fortified orange juice (controls). Subjects in all groups will drink two 8-oz. glasses of juice at least six hours apart (morning and afternoon) per day for a period of 12 weeks. Subjects randomized to intervention A will receive 200 IU vitamin D and 700 mg of calcium per day in 2 glasses of juice, intervention B will receive 200 IU vitamin D, 12 IU vitamin E, 2000 IU vitamin A as beta carotene, and 700 mg of calcium per day in 2 glasses of juice, while controls will receive 700 mg of calcium per day in 2 glasses of juice. A blood sample will be obtained before the subjects begin drinking the orange juice and at week 12 to determine levels of 25(OH)D which is a measure of vitamin D status. Blood will also be used for d
Interventions
- DIETARY_SUPPLEMENT Vitamin D
- DIETARY_SUPPLEMENT Vitamin D, Vitamin E, and Vitamin A
- DIETARY_SUPPLEMENT Control, 700 mg Calcium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2005-01 |
| Est. Completion | 2008-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01909063
The ClinicalTrials.gov registry entry for NCT01909063 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston University, which has 185 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Vitamin D is the first listed.
NCT01909063 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01909063 about?
NCT01909063 is a clinical study titled "A Randomized Controlled Trial Testing The Effect Of A Multi-Nutrient Fortified Juice". 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 status children ages 6-10 that are seen at the Division of Pediatrics at Boston University Medical Cen...
What is the current status of trial NCT01909063?
This trial is currently completed. It is a NA study. The enrollment target is 180 participants. The study started on 2005-01. Estimated completion is 2008-01.
What interventions are being tested in trial NCT01909063?
The interventions under investigation include: Vitamin D (DIETARY_SUPPLEMENT), Vitamin D, Vitamin E, and Vitamin A (DIETARY_SUPPLEMENT), Control, 700 mg Calcium (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01909063?
This trial is sponsored by Boston University, which has 185 total clinical trials registered on ClinicalTrials.gov.
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