Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000061235
Ethics application status
Approved
Date submitted
5/12/2008
Date registered
23/01/2009
Date last updated
23/01/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the efficacy of different strategies to treat anemia in Mexican children
Scientific title
Evaluation of the efficacy of different strategies to treat anemia in Mexican children: A randomized clinical trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anemia 4071 0
Condition category
Condition code
Public Health 4277 4277 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Children consumed on a daily basis during 4 months one of the following treatments:
1.- A standard ferrous sulfate supplement made in liquid solution. The daily dosage was 1mL containing ferrous sulfate (20mg).
2.- A daily iron and folic acid recommendation of UNICEF to treat anemia in a liquid solution. The daily dosage was 1mL containing iron (12.5mg) and folic acid (50ug).
3.- A multiple micronutrients supplement following a formula designed to treat anemia in indigenous population in Mexico. The daily dosage was 1mL containing iron (10mg), zinc (10mg), thiamine (0.6mg), Riboflavin (0.55mg), pyridoxin (0.75mg), vitamin B12 (0.55 ug), folic acid (37.5ug) and vitamin C (30mg).
4.- A powdered complementary food designed for a national program in Mexico (Oportunidades program formerly called Progresa program). The powder was prepared with a small amount of water to form a porridge which was eaten with the help of a spoon. The daily dosage was 44g containing iron (2.5mg), zinc (2mg), thiamine (0.18mg), riboflavin (0.32mg), vitamin B12 (0.42ug), folic Acid (10.1ug), vitamin C (2.4mg), vitamin A (330UI), vitamin E (2.5mg), vitamin D (100UI), vitamin B6 (0.2mg), vitamin K (6ug), niacin (2.3mg), pantothenic acid (0.6mg), biotin (4ug), calcium (200mg), phosphorus (160mg), magnesium (20mg), iodine (38ug), manganese (0.26mg), cupper (0.18mg), potassium (300mg) ahd chloride (220mg).
5.- A drink water product fortified with iron, zinc and ascorbic acid developed by Procter and Gamble (Cincinnati, OH). Water should be consumed when giving drinking water and when cooking for the child, there was no specified dose. 1L of watter contained iron (7.5mg), zinc (6.25mg) and vitamin C (50mg).
Intervention code [1] 3791 0
Treatment: Other
Comparator / control treatment
All treatments. Since all children were anemic, a placebo treatment was not included for ethical reasons.
Control group
Active

Outcomes
Primary outcome [1] 5164 0
Hemoglobin concentration. Hemoglobin was measured in a drop of capillar blood with a photometer (HemoCue Blood-Hemoglobin System, Angelholm, Sweden)
Timepoint [1] 5164 0
Baseline and after 4 months
Secondary outcome [1] 8693 0
Anthropometry. Children were weighted with an electronic scale with no shoes or sweaters to the nearest 100g. Height was measured with a stadiometer with no shoes. Younger children who could not stand still by themselves were weighted with a pediatric scale and their supine length was measured within 1mm using a rigid measuring mat for infants.
Timepoint [1] 8693 0
Baseline and after 4 months
Secondary outcome [2] 8694 0
Morbidity. A questionnaire was developed to record daily symptoms of respiratory and gastrointestinal infections.
Timepoint [2] 8694 0
Twice a week daily symptoms were recorded during 4 months
Secondary outcome [3] 8695 0
Treatment acceptance. Weekly compliance was recorded weekly by fieldworkers by gathering empty bottles or pouches, and the non-empty were weighted. In additon a weekly questionnaire was administered to mothers with questions about children's behaviour during and after administering the treatment.
Timepoint [3] 8695 0
Once a week during 4 months
Secondary outcome [4] 8696 0
Total iron and ferritin concentrations. Total iron was determined by triplicate using an atomic absorption spectrophotometer . Ferritin was determined by triplicate by immunoradiometric assay.
Timepoint [4] 8696 0
Baseline and after 4 months

Eligibility
Key inclusion criteria
Hemoglobin concentration <11.7g/dL
Minimum age
6 Months
Maximum age
42 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Breastfeeding
Chronic gastroenteritis or any other severe illness.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
An initial screening was carried out in 574 children. A sample of capillary blood was taken from every child after an overnight fast for hemoglobin analysis. Children were divided into two groups regarding their hemoglobin status: Anemic if Hb < 11.7g/dL or non-anemic if it was equal or above this value. Of the 574 children 46% were anemic and were randomized into 1 of 5 treatments. Allocation involved contacting the holder of the allocation schedule who was "off-site".
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization procedures were carried out for 10 blocks of children that entered the study one at a time, ensuring homogeneous groups concerning hemoglobin status, age and gender. Also siblings were allocated to the same treatments to facilitate treatment administration by the mother. This randomization process was achieved with a program in SAS version 8.1 (SAS Institute Inc. Cary, NC) specifically developed for the purpose of this study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/03/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
266
Accrual to date
Final
Recruitment outside Australia
Country [1] 1428 0
Mexico
State/province [1] 1428 0
Queretaro

Funding & Sponsors
Funding source category [1] 4249 0
Commercial sector/Industry
Name [1] 4249 0
Procter and Gamble Company
Country [1] 4249 0
United States of America
Primary sponsor type
University
Name
Universidad Autonoma de Queretaro
Address
Av Ciencias SN
Juriquilla 76230
Queretaro, Qro.
Country
Mexico
Secondary sponsor category [1] 3822 0
None
Name [1] 3822 0
Address [1] 3822 0
Country [1] 3822 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6300 0
Committee on Biomedical Research in Humans of the University of Queretaro
Ethics committee address [1] 6300 0
Ethics committee country [1] 6300 0
Mexico
Date submitted for ethics approval [1] 6300 0
Approval date [1] 6300 0
02/09/2003
Ethics approval number [1] 6300 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29199 0
Address 29199 0
Country 29199 0
Phone 29199 0
Fax 29199 0
Email 29199 0
Contact person for public queries
Name 12356 0
Maria del Carmen Caamaño
Address 12356 0
Av Ciencias SN
Juriquilla 76230
Queretaro, Qro.
Country 12356 0
Mexico
Phone 12356 0
+52 442 1921200 (Ext. 5351)
Fax 12356 0
Email 12356 0
[email protected]
Contact person for scientific queries
Name 3284 0
Dr. Jorge Luis Rosado Loria
Address 3284 0
Av Ciencias SN
Juriquilla 76230
Queretaro, Qro.
Country 3284 0
Mexico
Phone 3284 0
+52 442 1921200 (Ext. 5351)
Fax 3284 0
Email 3284 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.