Condition category
Haematological Disorders
Date applied
24/01/2011
Date assigned
19/05/2011
Last edited
19/05/2011
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

Dr Samia Halileh

ORCID ID

Contact details

Birzeit University
Po Box 14
Ramallah
-
Palestinian Territory
+972 (0)59 965 3889
samia@birzeit.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Quasi study using two types of iron: a non-randomised controlled intervention trial

Acronym

Study hypothesis

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

Local Ethics Committee approved on the 1st September 2008

Study design

Quasi experimental non-randomised controlled intervention trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet (Arabic only)

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/11/2009

Overall trial end date

31/08/2010

Reason abandoned

Eligibility

Participant inclusion criteria

All infants attending the 4 and 6 months immunization

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

320 in each group

Participant 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

Recruitment start date

01/11/2009

Recruitment end date

31/08/2010

Locations

Countries of recruitment

Palestinian Territory

Trial participating centre

Birzeit University
Ramallah
-
Palestinian Territory

Sponsor information

Organisation

Institute of Community and Public Health (Palestinian Territory)

Sponsor details

c/o Associate Prof Rana Khatib
Birzeit University
PO Box 14
Birzeit
Ramallah
-
Palestinian Territory
+972 (0)2 298 2020
samia@birzeit.edu

Sponsor type

Research organisation

Website

http://birzeit.edu

Funders

Funder type

Research organisation

Funder name

Swedish International Development Cooperation Agency (SIDA) (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Palestine Solidarity Association (PGS) (Sweden)

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