![]() |
Beta test our new site.
|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
Tracking Information | |||||
---|---|---|---|---|---|
First Received Date ICMJE | August 5, 2011 | ||||
Last Updated Date | April 10, 2012 | ||||
Start Date ICMJE | October 2011 | ||||
Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Ferritin [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ] The Ferritin level in blood will be measured at the beginning of the study as one of the most important inclusion criteria. This also will be the base line of the study. After that randomization will be carried out and after two months (time frame which ferrous sulfate or iron aminoacid chelate would increase ferritin level in blood) ferritin level will be measured again as the primary outcome measure. |
||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT01412723 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
|
||||
Original Secondary Outcome Measures ICMJE |
|
||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Ferrous Sulfate Versus Iron Amino Acid Chelate | ||||
Official Title ICMJE | EFICACIA DEL HIERRO AMINOQUELADO COMPARADO CON EL SULFATO FERROSO COMO COMPLEMENTO ALIMENTARIO EN PREESCOLARES CON DEFICIENCIA DE HIERRO. | ||||
Brief Summary | Iron deficiency and depleted levels of iron are the most prevalent nutritional deficiency and the leading cause of anemia in the world; this can occur at any age, but preschool children are at particular risk of developing it. This condition may cause serious repercussions for life, being a public health threat of considerable importance worldwide. Food fortification is considered the most effective solution to counter this situation, because it can help more people than other solutions. It is going to carry out a community trial to compare the efficacy of ferrous sulfate with respect to iron amino acid chelate as a dietary supplement in preschool children of Medellin with depleted levels of iron; in terms of increasing ferritin levels in blood and maintain hemoglobin levels. It is hypothesized that at the end of the study the effect of milk fortified with iron amino acid chelate won't be less than the effect of fortified with ferrous sulfate. It is hoped that the results may contribute, albeit indirectly, to improve the health status of children with depleted levels of iron whom consume iron-fortified products. |
||||
Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
||||
Condition ICMJE | Iron Deficiency | ||||
Intervention ICMJE |
|
||||
Study Arms |
|
||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 64 | ||||
Completion Date | April 2012 | ||||
Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria: Children who
Exclusion Criteria: Children who
|
||||
Gender | Both | ||||
Ages | 2 Years to 5 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | Colombia | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01412723 | ||||
Other Study ID Numbers ICMJE | SFHA-01 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Jose María Maya Mejía, CES University | ||||
Study Sponsor ICMJE | CES University | ||||
Collaborators ICMJE |
|
||||
Investigators ICMJE |
|
||||
Information Provided By | CES University | ||||
Verification Date | April 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |