Intervention study to reduce the level of anaemia among infants
| ISRCTN | ISRCTN63098210 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63098210 |
| Secondary identifying numbers | N/A |
- 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
| Study design | Quasi experimental non-randomised controlled intervention trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet (Arabic only) |
| 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 | Haemoglobin level at 12 months |
| Secondary outcome measures | 1. Feeding practices 2. Side effects of iron preparation 3. Compliance information 4. Family history of thalassaemia 4. Measures obtained via interview after the mother has performed the blood test for her child and before the results of the blood test, i.e., before her next visit to the clinic |
| Overall study start date | 01/11/2009 |
| Completion date | 31/08/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 4 Months |
| Upper age limit | 6 Months |
| Sex | Both |
| Target number of participants | 320 in each group |
| 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
Sponsor information
Institute of Community and Public Health (Palestinian Territory)
Research organisation
Research organisation
c/o Associate Prof Rana Khatib
Birzeit University
PO Box 14
Birzeit
Ramallah
-
Palestine, State of
| Phone | +972 (0)2 298 2020 |
|---|---|
| samia@birzeit.edu | |
| Website | http://birzeit.edu |
Funders
Funder type
Research organisation
Swedish International Development Cooperation Agency (SIDA) (Sweden)
No information available
Palestine Solidarity Association (PGS) (Sweden)
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 |
