Comparison of the Efficacy and Acceptability of Three Types of Micronutrient Supplements in Ghana
Condition: Micronutrients
Study type: Interventional
Phase: Phase 4

Summary: 
      1. At 12 mo of age, all three intervention groups will have significantly better iron and
           vitamin A status than the NI group.

        2. Infants who receive the Foodlet or Nutributter will have significantly greater weight
           and length gains from 6 to 12 mo and higher indices of vitamin B6, riboflavin and zinc
           status at 12 mo of age than the infants who receive the sprinkles containing iron and
           vitamin A only.

        3. Infants who receive Nutributter will have significantly greater weight and length gains
           from 6 to 12 mo and higher indices of vitamin A and essential fatty acid (linoleic,
           alpha-linolenic and docosahexaenoic, DHA) status at 12 mo of age than the infants who
           receive the Foodlet or sprinkles.
    

Detailed description: 
      Study design

      We propose to conduct a randomized controlled study of infants recruited from Maternal and
      Child Health centers in the town of Koforidua, located in eastern Ghana. There are 8 such
      centers located in various parts of the town, each of which serves the mothers and children
      in the immediate vicinity. The vast majority of infants born in Koforidua are brought to the
      MCH centers beginning a few weeks after birth for monthly weight monitoring. A list of all
      infants attending the MCH centers who are approximately 5 mo of age, have no congenital
      abnormality or chronic disease, and are currently breastfed will be created during each
      clinic day. From these lists we will randomly select approximately 34 infants per month
      (during a recruitment period of 9 mo) who will be invited to participate in the intervention
      trial. These infants will then be randomly assigned to one of three groups:

        1. "Sprinkles" group: Will receive micronutrient Sprinkles beginning at 6 mo of age.

        2. "Foodlet" group: Will receive crushable multiple micronutrient tablet beginning at 6 mo
           of age.

        3. "Nutributter" group: Will receive fat-based supplement (Nutributter) beginning at 6 mo
           of age

      We have chosen not to include a negative control (placebo) group because there is a high rate
      of iron and vitamin A deficiency in this population, and we cannot leave children who are
      known to be anemic untreated during the 6-mo study period. Instead, we will assess a
      "Non-Intervention" (NI) group of infants at 12 mo of age, which will allow us to evaluate
      attained size and micronutrient status in the absence of any intervention. The NI group will
      be randomly selected from the subset of infants who were recorded on the MCH lists described
      above during the recruitment period for the intervention trial (and thus met the same
      selection criteria), but not randomly selected for the intervention trial. [We cannot take
      all of the infants who come to the MCH clinics each month because the field work would be
      unmanageable. Given the birth rate of 179/mo, there will be more than enough "left over" each
      month who won't be selected for the intervention, and from whom we can randomly select the
      non-intervention group once they reach 12 mo.] We plan to recruit approximately 9/mo for the
      NI group for a period of 9 months, starting 6 mo after we initiate recruitment for the
      intervention (i.e., when the "left-over" infants begin to reach 12 mo of age). The MCH lists
      will include contact information (address), so that we can find the NI mothers at 12 mo. When
      we contact them at 12 mo, we will confirm that their infants would have met the eligibility
      criteria for the intervention study (breastfed at 5 mo, and free of congenital abnormality,
      chronic disease or peanut allergy), and ask them to participate in the one-time assessment.
      At that time each NI family will be given compensation equivalent in value to the supplements
      provided to the intervention groups (such as a 6-mo supply of Nutributter).

      Study site The study will be conducted in Koforidua, which has a population of about 87,000
      and an average birth rate of 179/mo (between 1998 and 2001).

      The University of Ghana will administer the project and provide scientific and technical
      support for the study. It will also provide office space for administrative tasks and
      laboratories for biochemical analyses of blood samples. UC Davis will provide supervision of
      the study through the Project Manager (Seth Adu-Afarwuah, a doctoral student at UC Davis),
      and will order and ship all of the necessary supplies and equipment.

      Informed consent procedures: Approval for the study has been obtained from the UC Davis Human
      Subjects Review Committee and the University of Ghana (Noguchi Memorial Institute) Ethics
      Committee. Consent to conduct the study in the town will be obtained from the Koforidua
      Municipal Health Administration. Written consent to participate in the study will be obtained
      individually from the mothers of the infants. Consent forms explaining the purpose of the
      study, potential risks or discomfort, the rights of subjects and the benefits to the subjects
      will be available both in English and in the local language, Asante Twi. For illiterate
      mothers unable to read, the form will be read and explained to them in Asante Twi. To
      indicate their consent, mothers will be asked to either sign the consent form or thumb-print
      it.
    

Intervention name(s): Micronutrient supplements
Intervention type(s): Drug
Intervention MeSH terms: Micronutrients; Trace Elements
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: multiple micronutrient supplements; home-fortification; complementary foods; infants; Ghana