AnemiaNCT00822380
Evaluation of the Efficacy of Different Strategies to Treat Anemia in Mexican Children
A study testing Iron, Multiple micronutrients supplement and micronutrient fortified porridge powder in people with Anemia, run by Universidad Autonoma de Queretaro.
Trial summary
Anemia continues to be a major public health problem in many regions of the world and it is still not clear which strategy is more effective in children population in terms of adherence and efficacy. Read more about this study
- Who is it for?
- Ages 6 to 42 monthsHealthy volunteers can take part
- Conditions the study is for
- Anemia
- What is being tested?
- Iron, Multiple micronutrients supplement and micronutrient fortified porridge powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 680 participants
- Where
- No sites listed yet
- Study dates
- Mar 2003to Nov 2004
- 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 42 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Hemoglobin less than 11.7g/dL and above 7.0g/dL
Who cannot join
- Breastfeeding
- Chronic gastroenteritis
- Any other severe illness
About this study
Official title: Evaluation of the Efficacy of Different Strategies to Treat Anemia in Mexican Children: A Randomized Clinical Trial
Anemia continues to be a major public health problem in many regions of the world and it is still not clear which strategy is more effective in children population in terms of adherence and efficacy. The objective was to evaluate the efficacy and acceptance of several strategies that have been recently recommended to treat anemia on anemic children (6 to 43 mo):Iron supplement, iron+folic acid supplement, a multiple micronutrients supplement a micronutrient fortified complementary food in the form of porridge powder or zinc+iron+ascorbic acid fortified water.
- Conditions
- Anemia
- Being tested
- Iron, Multiple micronutrients supplement, micronutrient fortified porridge powder, Iron and ascorbic acid fortified water, Iron plus folic acid supplement
- Keywords
- Anemia, Iron, Children, Micronutrients
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IronDietary supplement
Daily 20mg of ferrous sulfate in liquid solution during 4 months
Multiple micronutrients supplementDietary supplement
Daily supplement with 10mg of iron plus several micronutrients following a formula designed to treat anemia in indigenous population in Mexico. During 4 months.
micronutrient fortified porridge powderDietary supplement
Daily powdered complementary food designed for a national program in Mexico with 10mg of iron plus several micronutrients during 4 months
Iron and ascorbic acid fortified waterDietary supplement
A drink water product fortified with 6.7 mg ofiron, zinc and ascorbic acid. This product was asked to be used for drinking and for cooking for the child during 4 months.
Iron plus folic acid supplementDietary supplement
Daily liquid solution following the daily iron (12.5mg)and folic acid recommendation of UNICEF to treat anemia during 4 months
| Study group | Role | What they receive |
|---|---|---|
| Anemic children | Experimental | Not described Receives: Dietary Supplement: Iron; Dietary Supplement: Multiple micronutrients supplement; Dietary Supplement: micronutrient fortified porridge powder; Dietary Supplement: Iron and ascorbic acid fortified water; Dietary Supplement: Iron plus folic acid supplement |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2009 (estimated)
- Study startMar 2003
- Primary completionNov 2003
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 680 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Queretaro
- Sponsor type
- University, hospital or other
- Collaborators
- Procter and Gamble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00822380
- Sponsor's protocol ID
- FNN2002-07
- Status last verified
- Jan 2009
- First submitted
- 13 Jan 2009
- Last updated
- 14 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Rosado JL, Gonzalez KE, Caamano Mdel C, Garcia OP, Preciado R, Odio M. Efficacy of different strategies to treat anemia in children: a randomized clinical trial. Nutr J. 2010 Sep 23;9:40. doi: 10.1186/1475-2891-9-40.
PubMed 20863398
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Different Strategies to Treat Anemia in Mexican Children: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00822380
- Acronym / sponsor ID
- FNN2002-07
- Conditions
- Anemia
- Keywords
- Anemia, Iron, Children, Micronutrients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 680 participants (actual)
- Lead sponsor
- Universidad Autonoma de QueretaroUniversity, hospital or other
- Collaborators
- Procter and Gamble
- Study start
- Mar 2003
- Primary completion
- Nov 2003 (actual)
- Study completion
- Nov 2004 (actual)
- First posted
- 14 Jan 2009 (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.
Anemia continues to be a major public health problem in many regions of the world and it is still not clear which strategy is more effective in children population in terms of adherence and efficacy. The objective was to evaluate the efficacy and acceptance of several strategies that have been recently recommended to treat anemia on anemic children (6 to 43 mo):Iron supplement, iron+folic acid supplement, a multiple micronutrients supplement a micronutrient fortified complementary food in the form of porridge powder or zinc+iron+ascorbic acid fortified water.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anemic children | Experimental | Dietary Supplement: Iron, Dietary Supplement: Multiple micronutrients supplement, Dietary Supplement: micronutrient fortified porridge powder, Dietary Supplement: Iron and ascorbic acid fortified water, Dietary Supplement: Iron plus folic acid supplement |
Who may qualify
- Ages
- 6 to 42 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Hemoglobin less than 11.7g/dL and above 7.0g/dL
Key exclusion criteria (3 listed)
- Breastfeeding
- Chronic gastroenteritis
- Any other severe illness
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 |
|---|---|---|
| IronDaily 20mg of ferrous sulfate in liquid solution during 4 months | Dietary supplement | Anemic children |
| Multiple micronutrients supplementDaily supplement with 10mg of iron plus several micronutrients following a formula designed to treat anemia in indigenous population in Mexico. During 4 months. | Dietary supplement | Anemic children |
| micronutrient fortified porridge powderDaily powdered complementary food designed for a national program in Mexico with 10mg of iron plus several micronutrients during 4 months | Dietary supplement | Anemic children |
| Iron and ascorbic acid fortified waterA drink water product fortified with 6.7 mg ofiron, zinc and ascorbic acid. This product was asked to be used for drinking and for cooking for the child during 4 months. | Dietary supplement | Anemic children |
| Iron plus folic acid supplementDaily liquid solution following the daily iron (12.5mg)and folic acid recommendation of UNICEF to treat anemia during 4 months | Dietary supplement | Anemic children |
Primary outcome
Not reported in the source record.
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 14 Jan 2009.
- Derived from this study: PubMed 20863398Rosado JL, Gonzalez KE, Caamano Mdel C, Garcia OP, Preciado R, Odio M. Efficacy of different strategies to treat anemia in children: a randomized clinical trial. Nutr J. 2010 Sep 23;9:40. doi: 10.1186/1475-2891-9-40.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Iron, Multiple micronutrients supplement and micronutrient fortified porridge powder in people with Anemia, run by Universidad Autonoma de Queretaro.
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 1 inclusion and 3 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 14 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00822380, which also lists 1 linked publication.
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 14 Jan 2009.