Condition category
Neonatal Diseases
Date applied
13/10/2005
Date assigned
28/04/2006
Last edited
19/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.international-health.org/ARCH/

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

Publication citations

Additional files

Editorial Notes