Study Comparing Two Vitamin D Supplements for Infants: Liquid Versus D-Strips
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      Vitamin D supplementation (400 IU/d) is recommended for all breastfed infants in Canada. Such
      recommendation is grounded in the fact that the prevalence of rickets in Canada is higher
      than desirable, likely due to low maternal-fetal transfer and low intakes postpartum.

      There is little data about adherence to supplementation in Canada, but one study shows that
      in primiparous mothers (n=1937) in Quebec, 58.1 % of those exclusively breast-feeding gave
      their infant vitamin D supplements in the first six months and 62.1 % of those feeding
      formula did not. For the Canadian situation, it is not clear if the modality of the
      supplementation is a barrier to providing the supplement. Thus the overall aim of this study
      is to test a new delivery system for parental preference and infant acceptance compared to a
      standard vitamin D supplement.
    

Detailed description: 
      OBJECTIVES

        1. To determine parental preference for a new vitamin D delivery system over the standard
           of care supplement in syrup form.

        2. To determine infant acceptance for a new vitamin D delivery system over the standard of
           care supplement in syrup form.

        3. To establish possible barriers to either supplement delivery system being given during
           infancy.

      METHODOLOGY Design: randomized cross-over design, open label. Visit 1 (D1): written consent,
      demographic survey at first visit, randomize to order of supplement trial to begin with D
      Strip or syrup drops. obtain infant weight, complete health survey, instruct how to use
      supplement Call 1 (D4-D6): telephone call to address any questions or concerns, remind of
      next visit.

      Visit 2 (on or around D21): complete survey instrument for first supplement, obtain infant
      weight, complete health survey, instruct how to use second supplement Call 2: (D25-27):
      telephone call to address any questions or concerns, remind of next visit.

      Visit 3 (on or around D42): complete survey instruments, obtain infant weight; education
      regarding continued use of vitamin D.

      Demographics: Information related to demographics will be obtained at the baseline research
      visit. This survey (see appendix) includes questions related to parent education, income, and
      knowledge of vitamin D and prior supplementation practices. This information is important to
      help understand if parents of all backgrounds accept the supplement delivery systems.

      Delivery Systems: Both delivery systems will provide 400 IU of vitamin D3 in accordance with
      Health Canada's recommendation for all breastfed infants to receive a daily supplement until
      such dosage can be achieved through other foods (1). The standard delivery system is syrup
      administered in 1 ml volumes using a dropper. The syrup is typically given in the pockets
      between the gums and cheeks or slowly on the tongue. The new system is a D Strip that is a
      small rectangular strip administered on the oral palate (roof of the mouth), inner cheek, or
      surface of the tongue where it readily adheres and dissolves. Both can be given before or
      after feeding. The standard liquid supplement will be commercially-available product.

      Protocol and Testing: Parents of newborn infants will be asked to participate in the study.
      In total 50 infants will be studied at baseline beginning at 2 to 4 weeks of age and followed
      for a total of 6 weeks. At baseline Day 1 (Visit 1) and the beginning of the second study
      phase a general health assessment questionnaire will be administered. This includes maternal
      weight and height plus infant weight and overall health of the infant (i.e. any existing
      illnesses). Should the infant be unwell due to infections such as a common cold at that time,
      the parent will be asked to begin the study 1 week later provided that the illness has
      resolved. At Visit 1, parents will be asked demographic information and randomized to either
      the syrup group or the D Strip group. A registered nurse will show parents how to take the
      supplement. Then the infant will be weighed if not already done and enough supplement
      provided for 3 weeks. The first dose of the supplement will then be administered to the
      infant by the parent in the presence of the nurse. Parents will be informed that a care-call
      (Call 1) will be made at Day 4 to 6 into the study to establish if they have any questions or
      concerns. After 3 weeks (i.e. on or around Day 21, but not before the infant has completed 21
      days of supplement) the parents and infant will return (Visit 2) to the research site to
      complete surveys, have the infant weighed and be shown how to administer the other
      supplement. Again enough supplement will be given and parents informed of a care-call (Call
      2) at 4 to 6 days into the supplement trial (i.e. on Day 25-27). The first dose of the
      supplement will then be administered to the infant by the parent in the presence of the
      nurse. After 3 weeks (i.e. on or around Day 42, but not before the infant has completed 21
      days of supplement) they return for a final visit (Visit 3) to complete surveys
      (self-administered or with assistance) and have the infant weighed. At this visit, which is
      the end of study, parents will be given education about the importance of giving their infant
      vitamin D supplementation until 400 IU can be obtained from food.

      Two testing approaches will be used (see appendix) at the end of each study phase. First a
      validated questionnaire will be used, the medication acceptance scale (MAS), will be used to
      learn of infant acceptance. The effectiveness and infant acceptance of medications delivered
      through various modalities has been tested using a MAS designed and validated for pediatric
      oral liquids (21). This scale uses a point scale generated by observed behavior as related to
      4 main areas and has been slightly modified for our use. The second approach will be to
      administer a parent preference questionnaire using a Likert item response on a scale from 1
      to 10.

      Compliance Record: To establish compliance with giving daily supplementation three approaches
      will be taken.

        1. Each supplement will be provided in a box with a label fixed to the front upon which
           parents will initial every dosage given;

        2. Parents will be asked for frequency of dosage over each study phase; and

        3. Parents will be asked to return remaining supplement at the end of each study phase.
           Either a count for the D Strip or a weight for the syrup will confirm appropriate number
           of dosages given.

      Compliance will primarily be determined by the returned supplement count. If supplement is
      not returned, parent recollection of frequency of dosage will be used.
    

Intervention name(s): Vitamin D, cholecalciferol; Vitamin D, cholecalciferol
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Oral Quick Dissolve Strip, 400 IU once per day for 21 days; Oral Syrup, 400IU per day for 21 days
Other intervention name(s): BabyVita Vitamin D
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Healthy; Infants; Vitamin D