A Randomized Controlled Trial Testing The Effect Of A Multi-Nutrient Fortified Juice
1 other identifier
interventional
180
1 country
1
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 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 determining osteocalcin, parathyroid hormone (PTH), alkaline phosphatase, phosphorus, calcium, C-telopeptide (CTX), albumin, vitamin A, and vitamin E. A blood sample will also be obtained at week 6 for 25(OH)D and PTH.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2005
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 25, 2012
CompletedFirst Posted
Study publicly available on registry
July 26, 2013
CompletedFebruary 28, 2017
February 1, 2017
3 years
June 25, 2012
February 27, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Improve Vitamin A, Vitamin E, and Vitamin D Status in Children
The primary outcome of this study is to determine if 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.
12 weeks
Study Arms (3)
Arm A
EXPERIMENTAL200 IU vitamin D and 700 mg of calcium per day in 2 glasses of juice per day for 2 weeks
Arm B
EXPERIMENTAL200 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 Vitamin D, Vitamin E, and Vitamin A
Arm C
PLACEBO COMPARATORControl, 700 mg of calcium per day in 2 glasses of juice Control, 700 mg Calcium
Interventions
Fortification of orange juice with 200 IU vitamin D to be drunk twice per day for 12 weeks
Fortification of orange juice with Vitamin D, Vitamin E, and Vitamin A to be drunk twice per day for 12 weeks
Orange juice with 700 mg calcium to be drunk twice per day for 12 weeks
Eligibility Criteria
You may qualify if:
- \. Male and female children of all races with ages between 6 and 10
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Boston Medical Center
Boston, Massachusetts, 02118, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Micahel F Holick, PhD, MD
BUMC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 25, 2012
First Posted
July 26, 2013
Study Start
January 1, 2005
Primary Completion
January 1, 2008
Study Completion
January 1, 2008
Last Updated
February 28, 2017
Record last verified: 2017-02