AnemiaNCT00701246
Treatment and Prevention of Anemia With Ferrous Sulfate Plus Folic Acid in Children in Goiania - Goias, Brazil
A study testing ferrous sulfate and folic acid in people with Anemia, run by Universidade Federal de Goias at 1 site in Brazil.
Trial summary
Iron deficiency anemia is the most common nutritional problem in the world. The objectives of this study are: to evaluate the prevalence of anemia in children from 6 to 24 months of age and the therapeutic and prophylactic response to ferrous sulfate plus folic acid on hemoglobin levels. Read more about this study
- Who is it for?
- Ages 6 to 24 months
- Conditions the study is for
- Anemia
- What is being tested?
- ferrous sulfate and folic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 196 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2005to Mar 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- from 6 to 24 months
- born at term
- non-twins
- with parental approval for participation in the study
- attending municipal daycare centers with mor than four children each
Who cannot join
- Children with special needs
- low birth weight (<2.500g)
- with growth-impairing heart diseases
- neurological syndromes
- sickle-cell anemia
- sickle-cell trait
Show all 10Show fewer
- under treatment for anemia at the time of the first interview or screening performed by the pediatrician
- those no longer attending the daycare center
- the clinical trial excluded children with hemoglobin >=7 amd <=8g/dL.
- For the second objective: incomplete anthropometric surveys
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutritional Anemia: Prevention and Treatment in Early Childhood
Iron deficiency anemia is the most common nutritional problem in the world.
The objectives of this study are:
- to evaluate the prevalence of anemia in children from 6 to 24 months of age and the therapeutic and prophylactic response to ferrous sulfate plus folic acid on hemoglobin levels.
- to compare the effect of folic acid supplementation with ferrous sulfate on the linear and weight growth of anemic and non-anemic
Study hypothesis:
- The ferrous sulfate plus folic acid can improve the response on hemoglobin levels.
- The folic acid supplementation with ferrous sulfate have effect on the linear and weight growth of anemic and non-anemic.
Read the detailed description
Purpose
The objective of this study were:
- to assess the prevalence of anemia and the therapeutic and prophylactic response to ferrous sulfate and folic acid.
- to compare the effect of folic acid supplementation with ferrous sulfate on the linear and weight growth of anemic and non-anemic.
A double-blind, randomized, controlled clinical trial was conducted with 196 children 6 to 24 months of age enrolled in municipal daycare centers in Goiânia, Goias State, Brazil. The children were assigned to two treatment groups that received a daily dose (5 times a week) of either 4.2mg/kg/day of ferrous sulfate + folic acid (50μg) or 4.2mg/kg/day of ferrous sulfate + folic acid placebo. One of the prevention groups received 1.4mg/kg/day of ferrous sulfate + folic acid (50μg/day) and the other 1.4mg/kg/day of ferrous sulfate + folic acid placebo. Supplementation lasted approximately three months.
- Conditions
- Anemia
- Being tested
- ferrous sulfate, folic acid, placebo (folic acid)
- Keywords
- Anemia, Iron deficiency anemia, Infants, Children, Clinical trials, Ferrous sulfate, Folic acid, Daycare centers, Anaemia in children, born at term, non-twins, with parental approval for participation in the study, growth
- Medical subject headings
- Anemia, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ferrous sulfateDrug
folic acidDrug
placebo (folic acid)Drug
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | I Treatment: a daily dose (5 times a week) of either 4,2 mg/kg/day of ferrous sulfate + folic acid (50 mcg) Receives: Drug: ferrous sulfate; Drug: folic acid |
| II | Placebo comparator | II Treatment of anemic children with 4,2 mg/kg/day of ferrous sulfate and folic acid placebo. Receives: Drug: ferrous sulfate; Drug: placebo (folic acid) |
| III | Experimental | Prevention of anemia in non-anemic children ( 5 times a week)- 1,4 mg/kg/day of ferrous sulfate and folic acid Receives: Drug: ferrous sulfate; Drug: folic acid |
| IV | Placebo comparator | 1,4 mg/kg/day of ferrous sulfate plus folic acid placebo, five days a week. Receives: Drug: ferrous sulfate; Drug: placebo (folic acid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iron status
Measured: Approximately three months
Secondary outcomes (1)
Prevalence of anemia
Measured: Approximately three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2008 (estimated)
- Study startApr 2005
- Primary completionMar 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Goias
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of São Paulo, Ministry of Health, Brazil, Goiania Municipal Health Department
- Responsible party
- Principal investigator, Maria Claret Costa Monteiro Hadler, Universidade Federal de Goias
- Investigators
- Maria Claret CM Hadler, PhD Sciences, Principal investigator, Universidade Federal de GoiasDirce M Sigulem, MD, PhD, Principal investigator, Federal University of São PauloMaria de Fátima C Alves, PhD, Principal investigator, Universidade Federal de GoiasVinícius M Torres, MD, Principal investigator, Vila São José Bento CotolengoDaniela AM Dias, MSc., Principal investigator, Faculty of Nutrition of Federal University of GoiasAndréa Sugai, PhD., Principal investigator, Faculty of Nutrition - Federal University of Goias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00701246
- Sponsor's protocol ID
- FANUT 302004
- Status last verified
- Mar 2014
- First submitted
- 18 Jun 2008
- Last updated
- 13 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Wieringa FT, Dijkhuizen MA, van der Ven-Jongekrijg J, West CE, Muhilal, van der Meer JW. Micronutrient deficiency and supplementation in Indonesian infants. Effects on immune function. Adv Exp Med Biol. 2003;531:369-77. doi: 10.1007/978-1-4615-0059-9_31. No abstract available.
PubMed 12916807Allen LH, Rosado JL, Casterline JE, Lopez P, Munoz E, Garcia OP, Martinez H. Lack of hemoglobin response to iron supplementation in anemic mexican preschoolers with multiple micronutrient deficiencies. Am J Clin Nutr. 2000 Jun;71(6):1485-94. doi: 10.1093/ajcn/71.6.1485.
PubMed 10837289Hadler MC, Juliano Y, Sigulem DM. [Anemia in infancy: etiology and prevalence]. J Pediatr (Rio J). 2002 Jul-Aug;78(4):321-6. Portuguese.
PubMed 14647764Hadler MC, Colugnati FA, Sigulem DM. Risks of anemia in infants according to dietary iron density and weight gain rate. Prev Med. 2004 Oct;39(4):713-21. doi: 10.1016/j.ypmed.2004.02.040.
PubMed 15351537Geltman PL, Meyers AF, Mehta SD, Brugnara C, Villon I, Wu YA, Bauchner H. Daily multivitamins with iron to prevent anemia in high-risk infants: a randomized clinical trial. Pediatrics. 2004 Jul;114(1):86-93. doi: 10.1542/peds.114.1.86.
PubMed 15231912Sazawal S, Black RE, Ramsan M, Chwaya HM, Stoltzfus RJ, Dutta A, Dhingra U, Kabole I, Deb S, Othman MK, Kabole FM. Effects of routine prophylactic supplementation with iron and folic acid on admission to hospital and mortality in preschool children in a high malaria transmission setting: community-based, randomised, placebo-controlled trial. Lancet. 2006 Jan 14;367(9505):133-43. doi: 10.1016/S0140-6736(06)67962-2.
PubMed 16413877Hadler MC, Sigulem DM, Alves Mde F, Torres VM. Treatment and prevention of anemia with ferrous sulfate plus folic acid in children attending daycare centers in Goiania, Goias State, Brazil: a randomized controlled trial. Cad Saude Publica. 2008;24 Suppl 2:S259-71. doi: 10.1590/s0102-311x2008001400011.
PubMed 18670706
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Anemia: Prevention and Treatment in Early Childhood
- ClinicalTrials.gov ID
- NCT00701246
- Acronym / sponsor ID
- FANUT 302004
- Conditions
- Anemia
- Keywords
- Anemia, Iron deficiency anemia, Infants, Children, Clinical trials, Ferrous sulfate, Folic acid, Daycare centers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Universidade Federal de GoiasUniversity, hospital or other
- Collaborators
- Federal University of São Paulo, Ministry of Health, Brazil, Goiania Municipal Health Department
- Study start
- Apr 2005
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 19 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Iron deficiency anemia is the most common nutritional problem in the world.
The objectives of this study are:
- to evaluate the prevalence of anemia in children from 6 to 24 months of age and the therapeutic and prophylactic response to ferrous sulfate plus folic acid on hemoglobin levels.
- to compare the effect of folic acid supplementation with ferrous sulfate on the linear and weight growth of anemic and non-anemic
Study hypothesis:
- The ferrous sulfate plus folic acid can improve the response on hemoglobin levels.
- The folic acid supplementation with ferrous sulfate have effect on the linear and weight growth of anemic and non-anemic.
Detailed description
Purpose
The objective of this study were:
- to assess the prevalence of anemia and the therapeutic and prophylactic response to ferrous sulfate and folic acid.
- to compare the effect of folic acid supplementation with ferrous sulfate on the linear and weight growth of anemic and non-anemic.
A double-blind, randomized, controlled clinical trial was conducted with 196 children 6 to 24 months of age enrolled in municipal daycare centers in Goiânia, Goias State, Brazil. The children were assigned to two treatment groups that received a daily dose (5 times a week) of either 4.2mg/kg/day of ferrous sulfate + folic acid (50μg) or 4.2mg/kg/day of ferrous sulfate + folic acid placebo. One of the prevention groups received 1.4mg/kg/day of ferrous sulfate + folic acid (50μg/day) and the other 1.4mg/kg/day of ferrous sulfate + folic acid placebo. Supplementation lasted approximately three months.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Drug: ferrous sulfate, Drug: folic acidI Treatment: a daily dose (5 times a week) of either 4,2 mg/kg/day of ferrous sulfate + folic acid (50 mcg) |
| II | Placebo comparator | Drug: ferrous sulfate, Drug: placebo (folic acid)II Treatment of anemic children with 4,2 mg/kg/day of ferrous sulfate and folic acid placebo. |
| III | Experimental | Drug: ferrous sulfate, Drug: folic acidPrevention of anemia in non-anemic children ( 5 times a week)- 1,4 mg/kg/day of ferrous sulfate and folic acid |
| IV | Placebo comparator | Drug: ferrous sulfate, Drug: placebo (folic acid)1,4 mg/kg/day of ferrous sulfate plus folic acid placebo, five days a week. |
Who may qualify
- Ages
- 6 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- from 6 to 24 months
- born at term
- non-twins
- with parental approval for participation in the study
- attending municipal daycare centers with mor than four children each
Key exclusion criteria (10 listed)
- Children with special needs
- low birth weight (<2.500g)
- with growth-impairing heart diseases
- neurological syndromes
- sickle-cell anemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ferrous sulfate | Drug | I, II, III, IV |
| folic acid | Drug | I, III |
| placebo (folic acid) | Drug | II, IV |
Primary outcome
Iron status
Time frame: Approximately three months
1 secondary outcome
Prevalence of anemia
Time frame: Approximately three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2014.
- Background: PubMed 12916807Wieringa FT, Dijkhuizen MA, van der Ven-Jongekrijg J, West CE, Muhilal, van der Meer JW. Micronutrient deficiency and supplementation in Indonesian infants. Effects on immune function. Adv Exp Med Biol. 2003;531:369-77. doi: 10.1007/978-1-4615-0059-9_31. No abstract available.
- Background: PubMed 10837289Allen LH, Rosado JL, Casterline JE, Lopez P, Munoz E, Garcia OP, Martinez H. Lack of hemoglobin response to iron supplementation in anemic mexican preschoolers with multiple micronutrient deficiencies. Am J Clin Nutr. 2000 Jun;71(6):1485-94. doi: 10.1093/ajcn/71.6.1485.
- Background: PubMed 14647764Hadler MC, Juliano Y, Sigulem DM. [Anemia in infancy: etiology and prevalence]. J Pediatr (Rio J). 2002 Jul-Aug;78(4):321-6. Portuguese.
- Background: PubMed 15351537Hadler MC, Colugnati FA, Sigulem DM. Risks of anemia in infants according to dietary iron density and weight gain rate. Prev Med. 2004 Oct;39(4):713-21. doi: 10.1016/j.ypmed.2004.02.040.
- Background: PubMed 15231912Geltman PL, Meyers AF, Mehta SD, Brugnara C, Villon I, Wu YA, Bauchner H. Daily multivitamins with iron to prevent anemia in high-risk infants: a randomized clinical trial. Pediatrics. 2004 Jul;114(1):86-93. doi: 10.1542/peds.114.1.86.
- Background: PubMed 16413877Sazawal S, Black RE, Ramsan M, Chwaya HM, Stoltzfus RJ, Dutta A, Dhingra U, Kabole I, Deb S, Othman MK, Kabole FM. Effects of routine prophylactic supplementation with iron and folic acid on admission to hospital and mortality in preschool children in a high malaria transmission setting: community-based, randomised, placebo-controlled trial. Lancet. 2006 Jan 14;367(9505):133-43. doi: 10.1016/S0140-6736(06)67962-2.
- Results publication: PubMed 18670706Hadler MC, Sigulem DM, Alves Mde F, Torres VM. Treatment and prevention of anemia with ferrous sulfate plus folic acid in children attending daycare centers in Goiania, Goias State, Brazil: a randomized controlled trial. Cad Saude Publica. 2008;24 Suppl 2:S259-71. doi: 10.1590/s0102-311x2008001400011.
- Publication of the articleLink provided by the sponsor.
- Erratum of the titleLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Claret CM Hadler, PhD Sciences principal investigator
Universidade Federal de Goias
Dirce M Sigulem, MD, PhD principal investigator
Federal University of São Paulo
Maria de Fátima C Alves, PhD principal investigator
Universidade Federal de Goias
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ferrous sulfate and folic acid in people with Anemia, run by Universidade Federal de Goias at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Iron status (time frame: Approximately three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00701246, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2014.