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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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12 February 2013 |
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Main ID: |
ISRCTN35833344 |
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Date of registration:
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28/04/2006 |
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Primary sponsor: |
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Public title:
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Multiple micro-nutrient supplementation of low-birth-weight infants in Pakistan: a randomised controlled trial
MICR |
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Scientific title:
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Date of first enrolment:
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May 1 1999 |
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Target sample size:
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400 infants in each arm (two groups) |
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Recruitment status: |
Completed/Not recruiting |
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URL:
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http://isrctn.org/ISRCTN35833344 |
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Study type:
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Interventional |
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Study design:
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Double-blind randomised placebo-controlled trial
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Countries of recruitment
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Pakistan
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Contacts
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Name:
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Zulfiqar Ahmed
Bhutta |
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Address:
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Department of Pediatrics
Aga Khan University
Stadium Road
74800
Karachi
Pakistan |
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Telephone:
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+92 21 486 4721 |
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Email:
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zulfiqar.bhutta@aku.edu |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Six to twelve month old infants identified after birth at tertiary care hospital
Exclusion criteria: 1. Children with major congenital or chronic disorders
2. Loss to follow up
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Low-birth-weight infants
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Intervention(s)
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The infants were exclusively breastfed and received the supplement or placebo daily for six months. The infants were followed up at home at mostly intervals by teams of research medical officers and community health nurses, up till 12 months of age.
Following informed written consent the newborn infants were randomised to the following treatment groups in a blinded fashion using randomisation codes in blocks of 20. The randomisation codes were kept at the Aga Khan University Pharmacy Department and were available on phone to the research teams.
Group A: received a one daily oral supplement providing moisture of iron, copper, zinc, vitamin A and D for six months along with the recommended daily allowance (RDA) of a standard multivitamin mixture (Surbex, Abbot) for six months
Group B: received a placebo daily and standard multivitamin moisture (Surbex, Abbott)
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Primary Outcome(s)
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1. Growth (weight gain and linear growth)
2. Morbidity rates (days ill with diarrhea and respiratory infections)
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Secondary Outcome(s)
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Neurodevelopmental outcome at 6 and 12 months. This will be objectively evaluated in a blinded fashion by a team comprising of a pediatric neurologist and fully trained child development expert.
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Source(s) of Monetary Support
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Applied Research on Child Health Project (ARCH) (USA)
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