Multiple micro-nutrient supplementation of low-birth-weight infants in Pakistan: a randomised controlled trial

ISRCTN	ISRCTN35833344
DOI	https://doi.org/10.1186/ISRCTN35833344
Secondary identifying numbers	9907

Submission date: 13/10/2005
Registration date: 28/04/2006
Last edited: 19/10/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Neonatal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Zulfiqar Ahmed Bhutta
Scientific

Department of Pediatrics
Aga Khan University
Stadium Road
Karachi
74800
Pakistan

Phone	+92 21 486 4721
Email	zulfiqar.bhutta@aku.edu

Study information

Study design	Double-blind randomised placebo-controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Quality of life
Scientific title
Study acronym	MICR
Study objectives	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(s)	Approved by the Ethical Review Committee of Aga Khan University Karachi, Pakistan in September 2001 with the reference number 100-Ped/ERC-01
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/05/1999
Completion date	01/05/2002

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	Both
Target number of participants	400 infants in each arm (two groups)
Key inclusion criteria	Six to twelve month old infants identified after birth at tertiary care hospital
Key exclusion criteria	1. Children with major congenital or chronic disorders 2. Loss to follow up
Date of first enrolment	01/05/1999
Date of final enrolment	01/05/2002

Locations

Countries of recruitment

Pakistan

Study participating centre

Department of Pediatrics

Karachi
74800
Pakistan

Sponsor information

Applied Research on Child Health Project (ARCH) (USA)
Charity

Center for International Health
Boston University
School of Public Health
715 Albanay Street
710
Boston
MA 02118
United States of America

Phone	+1 617 414 1260
Email	archcih@bu.edu
Website	http://www.international-health.org/ARCH/

Funders

Funder type

Research organisation

Applied Research on Child Health Project (ARCH) (USA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan