Contact information
Type
Scientific
Primary contact
Prof Zulfiqar Ahmed Bhutta
ORCID ID
Contact details
Department of Pediatrics
Aga Khan University
Stadium Road
Karachi
74800
Pakistan
+92 21 486 4721
zulfiqar.bhutta@aku.edu
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
9907
Study information
Scientific title
Acronym
MICR
Study hypothesis
A six-month supplementation with a combination of vitamin A, iron, zinc, copper, folic acid and vitamin D will improve growth of infants
Ethics approval
Approved by the Ethical Review Committee of Aga Khan University Karachi, Pakistan in September 2001 with the reference number 100-Ped/ERC-01
Study design
Double-blind randomised placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Condition
Low-birth-weight infants
Intervention
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)
Intervention type
Supplement
Phase
Not Specified
Drug names
Vitamin A and D, iron, zinc, copper and folic acid
Primary outcome measures
1. Growth (weight gain and linear growth)
2. Morbidity rates (days ill with diarrhea and respiratory infections)
Secondary outcome measures
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.
Overall trial start date
01/05/1999
Overall trial end date
01/05/2002
Reason abandoned
Eligibility
Participant inclusion criteria
Six to twelve month old infants identified after birth at tertiary care hospital
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
400 infants in each arm (two groups)
Participant exclusion criteria
1. Children with major congenital or chronic disorders
2. Loss to follow up
Recruitment start date
01/05/1999
Recruitment end date
01/05/2002
Locations
Countries of recruitment
Pakistan
Trial participating centre
Department of Pediatrics
Karachi
74800
Pakistan
Sponsor information
Organisation
Applied Research on Child Health Project (ARCH) (USA)
Sponsor details
Center for International Health
Boston University
School of Public Health
715 Albanay Street
710
Boston
MA 02118
United States of America
+1 617 414 1260
archcih@bu.edu
Sponsor type
Charity
Website
Funders
Funder type
Research organisation
Funder name
Applied Research on Child Health Project (ARCH) (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary