Multiple micro-nutrient supplementation of low-birth-weight infants in Pakistan: a randomised controlled trial
| ISRCTN | ISRCTN35833344 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35833344 |
| Protocol serial number | 9907 |
| Sponsor | Applied Research on Child Health Project (ARCH) (USA) |
| Funder | Applied Research on Child Health Project (ARCH) (USA) |
- 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
Scientific
Department of Pediatrics
Aga Khan University
Stadium Road
Karachi
74800
Pakistan
| Phone | +92 21 486 4721 |
|---|---|
| zulfiqar.bhutta@aku.edu |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double-blind randomised placebo-controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
1. Growth (weight gain and linear growth) |
| Key secondary outcome measure(s) |
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. |
| Completion date | 01/05/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | All |
| Target sample size at registration | 800 |
| 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
74800
Pakistan
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
