Ferrous Sulfate Versus Iron Amino Acid Chelate
Primary Purpose
Iron Deficiency
Status
Completed
Phase
Phase 3
Locations
Colombia
Study Type
Interventional
Intervention
Ferrous sulfate as dietary supplementation
Iron amino acid chelated as dietary supplementation
Sponsored by
About this trial
This is an interventional supportive care trial for Iron Deficiency focused on measuring Iron Deficiency, Child, Preschool, Dietary Iron, Ferrous sulfate, Bis-glycino iron II
Eligibility Criteria
Inclusion Criteria:
Children who
- Belong to institute FAN in Medellín
- Attend full time to institute FAN (eight hours)
- Have 2 to 5 years inclusive
- Submit depleted levels of iron (ferritin level equal to or less than 24 mg/L)
Exclusion Criteria:
Children who
- Submit anemia (hemoglobin level equal to or less than 11 g/dL)
- Have not stool analysis before intervention
Sites / Locations
- Universidad CES
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Ferrous sulphate
Iron Amino acid chelate
Arm Description
Preschool children with depleted levels of iron enrolled in FAN Foundation of Medellin, which will be supplied with ferrous sulfate-fortified milk
Preschool children with depleted levels of iron enrolled in FAN Foundation of Medellin , which will be supplied with iron amino acid chelate-fortified milk
Outcomes
Primary Outcome Measures
Ferritin
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.
Secondary Outcome Measures
Hemoglobin
The Hemoglobin level in blood will be measured at the beginning of the study as one of the most important exclusion criteria. 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) hemoglobin level will be measured again as one of secundary outcome measure. The hypothesis is that the hemoglobin level won't decrease
Infection
Daily written report of the caregiver during the intervention
Adverse reaction
The caregiver recorded daily if the child had an adverse reaction such as abdominal pain, nausea, vomiting, constipation, diarrhea, darkening of feces, and disgust for food.
Full Information
NCT ID
NCT01412723
First Posted
August 5, 2011
Last Updated
April 10, 2012
Sponsor
CES University
Collaborators
Nutreva S.A.S., Foundation Child Care - FAN
1. Study Identification
Unique Protocol Identification Number
NCT01412723
Brief Title
Ferrous Sulfate Versus Iron Amino Acid Chelate
Official Title
EFICACIA DEL HIERRO AMINOQUELADO COMPARADO CON EL SULFATO FERROSO COMO COMPLEMENTO ALIMENTARIO EN PREESCOLARES CON DEFICIENCIA DE HIERRO.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CES University
Collaborators
Nutreva S.A.S., Foundation Child Care - FAN
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency
Keywords
Iron Deficiency, Child, Preschool, Dietary Iron, Ferrous sulfate, Bis-glycino iron II
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ferrous sulphate
Arm Type
Active Comparator
Arm Description
Preschool children with depleted levels of iron enrolled in FAN Foundation of Medellin, which will be supplied with ferrous sulfate-fortified milk
Arm Title
Iron Amino acid chelate
Arm Type
Experimental
Arm Description
Preschool children with depleted levels of iron enrolled in FAN Foundation of Medellin , which will be supplied with iron amino acid chelate-fortified milk
Intervention Type
Other
Intervention Name(s)
Ferrous sulfate as dietary supplementation
Intervention Description
Ferrous sulfate as dietary supplementation
Intervention Type
Other
Intervention Name(s)
Iron amino acid chelated as dietary supplementation
Intervention Description
Iron amino acid chelated as dietary supplementation
Primary Outcome Measure Information:
Title
Ferritin
Description
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.
Time Frame
Up to 8 weeks
Secondary Outcome Measure Information:
Title
Hemoglobin
Description
The Hemoglobin level in blood will be measured at the beginning of the study as one of the most important exclusion criteria. 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) hemoglobin level will be measured again as one of secundary outcome measure. The hypothesis is that the hemoglobin level won't decrease
Time Frame
Up to 8 weeks
Title
Infection
Description
Daily written report of the caregiver during the intervention
Time Frame
Daily. During 2 months of intervention
Title
Adverse reaction
Description
The caregiver recorded daily if the child had an adverse reaction such as abdominal pain, nausea, vomiting, constipation, diarrhea, darkening of feces, and disgust for food.
Time Frame
Daily. During 2 months of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children who
Belong to institute FAN in Medellín
Attend full time to institute FAN (eight hours)
Have 2 to 5 years inclusive
Submit depleted levels of iron (ferritin level equal to or less than 24 mg/L)
Exclusion Criteria:
Children who
Submit anemia (hemoglobin level equal to or less than 11 g/dL)
Have not stool analysis before intervention
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana M Herrera, PhD en Patología
Organizational Affiliation
CES University
Official's Role
Study Director
Facility Information:
Facility Name
Universidad CES
City
Medellin
State/Province
Antioquia
Country
Colombia
12. IPD Sharing Statement
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Ferrous Sulfate Versus Iron Amino Acid Chelate
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