A Randomized Controlled Trial Testing The Effect Of A Multi-Nutrient Fortified Juice
Condition: Vitamin D Deficiency; Hypovitaminosis A; Vitamin E Deficiency
MeSH terms: Vitamin D Deficiency; Avitaminosis; Vitamin E Deficiency
Study type: Interventional

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.
    

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 Medical Center. Potential volunteers will undergo a screening process to ensure
      that inclusion and exclusion criteria are met. A general medical history will be taken before
      the study starts. A baseline biochemical profile (blood) including calcium, phosphorus,
      osteocalcin, alkaline phosphatase, C-telopeptide (CTX), 25(OH)D, PTH, albumin, vitamin A, and
      vitamin E will be determined after the study is completed. The amount of blood estimated to
      be drawn on the first visit is 27 ml. Dietary intake will be assessed from 3 day food records
      via NDS-Minnesota Database by Dr. Christine Economos, Friedman School of Nutrition Science
      and Policy at Tufts University. Once the subject has met the inclusion criteria, he/she will
      receive two gallons of orange juice via a delivery service to their home. He/she will be
      instructed to drink two 8 oz. glasses of orange juice a day and record each glass of juice
      that was drunk; stickers and calendars will be provided. A delivery service will be used to
      deliver juice to parents/caregiver biweekly. Signature and log sheets of deliveries will be
      maintained. A glass that has a mark designating eight ounces will be provided to the subject
      so that the amount of orange juice that is drunk is measured. Sixty subjects will receive
      intervention A, sixty subjects will receive intervention B, and sixty subjects will receive
      intention C. Subjects randomized to intervention A will receive juice that contains 200 IU of
      vitamin D and 700 mg of calcium per day. Subjects randomized to 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. Subjects randomized to intervention C will receive 700 mg calcium per day. A venous
      blood sample of 27 ml [two red top tubes (10ccs each) and one purple top tube (7ccs)] will be
      obtained at the initial and final visits. 25(OH)D, PTH, calcium, phosphorus, osteocalcin,
      C-telopeptide(CTX), alkaline phosphatase, albumin, vitamin A, and vitamin E will be measured
      from the blood samples. During the mid-intervention blood draw (week 6) 10mL of blood will be
      drawn and 25(OH)D and PTH will be measured. The study will consist of 12 weeks of drinking
      two eight-ounce glasses of orange juice a day (one in the am and one in the pm).
    

Intervention name(s): Vitamin D; Vitamin D, Vitamin E, and Vitamin A; Control, 700 mg Calcium
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 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
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins; Vitamin E; Vitamin A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment