Intervention study to reduce the level of anaemia among infants
| ISRCTN | ISRCTN63098210 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63098210 |
| Protocol serial number | N/A |
| Sponsor | Institute of Community and Public Health (Palestinian Territory) |
| Funders | Swedish International Development Cooperation Agency (SIDA) (Sweden), Palestine Solidarity Association (PGS) (Sweden) |
- Submission date
- 24/01/2011
- Registration date
- 19/05/2011
- Last edited
- 19/05/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
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
Dr Samia Halileh
Scientific
Scientific
Birzeit University
Po Box 14
Ramallah
-
Palestine, State of
| Phone | +972 (0)59 965 3889 |
|---|---|
| samia@birzeit.edu |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Quasi experimental non-randomised controlled intervention trial |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Quasi study using two types of iron: a non-randomised controlled intervention trial |
| Study objectives | The introduction of ferrous sulphate at 6 months is suboptimal to the introduction of polymaltose complex iron preparation at 4 months in reducing the level of anaemia at 12 months. Iron preparation needs to be introduced earlier, at 4 months not 6 months and polymaltose complex is more palatable and has less gastrointestinal effects compared to ferrous sulphate. |
| Ethics approval(s) | Local Ethics Committee approved on the 1st September 2008 |
| Health condition(s) or problem(s) studied | Anaemia |
| Intervention | 1. Ferrous sulphate (control group) 1.1. Dose is 2 mg/kg/day, starting at 6 months of age, giving 3 bottles to last for 3 months for when the next follow up visit is due 1.2. Total duration is 6 months 1.3. Haemoglobin measured at 12 months 2. Iron polymaltose complex (intervention group) 2.1. Dose is 2 mg/kg/day, starting at 4 months of age, giving 2 bottles, 3 bottles and another 3 bottles to coincide with visits at 4, 6, 9 months 2.2. Total duration is 8 months 2.3. Haemoglobin measured at 12 months. |
| Intervention type | Other |
| Primary outcome measure(s) |
Haemoglobin level at 12 months |
| Key secondary outcome measure(s) |
1. Feeding practices |
| Completion date | 31/08/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 4 Months |
| Upper age limit | 6 Months |
| Sex | All |
| Target sample size at registration | 640 |
| Key inclusion criteria | All infants attending the 4 and 6 months immunization |
| Key exclusion criteria | 1. Already taking iron 2. Pre-term or of low bith weight (only excluded if infants were already taking iron) 3. Mother refused consent 4. Does not have a file at the clinic |
| Date of first enrolment | 01/11/2009 |
| Date of final enrolment | 31/08/2010 |
Locations
Countries of recruitment
- Palestine, State of
Study participating centre
Birzeit University
Ramallah
-
Palestine, State of
-
Palestine, State of
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
