A Randomized Controlled Trial Testing The Effect Of A Multi-Nutrient Fortified Juice

Completed · Not applicable

Conditions studied: Vitamin D Deficiency, Hypovitaminosis A, Vitamin E Deficiency

In brief

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.

Key facts

Study ID

NCT01909063

Run by

Boston University

People needed

180

Starts

2005-01-01

Expected to finish

2008-01-01

Last updated by the study team

2017-02-28

Who can join

Age: 6 and older, up to 10. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• Boston Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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