MalnutritionPhase 3NCT01917032
Effect of Home-fortification With Sprinkles in Hematologic and Nutritional Status in Preschool Children in Medellín
A Phase 3 study testing Sachets containing a blend of micronutrients in powder form (Iron, Zinc, Folic Acid, Vitamin A and C), sprinkled onto home made food in people with Malnutrition, run by CES University at 1 site in Colombia.
Trial summary
Objective: To acquire the local scientific evidence, to evaluate the effects of micronutrient Sprinkles™ powder, both the nutritional status and haematological values in the vulnerable preschool population, to corroborate the reported benefits of the experiences in other countries. Read more about this study
- Who is it for?
- Ages 5 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Malnutrition
- What is being tested?
- Sachets containing a blend of micronutrients in powder form (Iron, Zinc, Folic Acid, Vitamin A and C), sprinkled onto home made food
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteColombia
- Study dates
- Sep 2013to Dec 2013
- Phase
- Phase 3
- 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 5 to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Assistance to children's centres full day (8 hours).
- Age 5 to 59 months.
Who cannot join
- Anemia (hemoglobin less than 11 g / dl).
- Current supplementation with a product formulated by a health professional as a part of a nutritional recovery.
- Denial for informed consent signing by parents or legal guardians.
- Diagnosis of severe acute malnutrition by anthropometric measurements.
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Fundación de Atención a la Niñez (FAN)
Medellín, Ant, 0574
Viviana Ramírez, Nutricionist, 5744480288, nutricion@fan.org.co
About this study
Official title: Effect of Home-fortification With Micronutrient Powder Sprinkles in Hematologic and Nutritional Status in Preschool Children in Medellín: a Randomized Clinical Trial.
Objective: To acquire the local scientific evidence, to evaluate the effects of micronutrient Sprinkles™ powder, both the nutritional status and haematological values in the vulnerable preschool population, to corroborate the reported benefits of the experiences in other countries.
Question: Will it improve the nutritional status and hematological levels after the home fortification with Sprinkles in children of two child care centres in the city of Medellin, in 2013?
Read more
Hypothesis: At the end of intervention, hematologic levels and anthropometric indicators will be better in the intervention group with Sprinkles, compared with the placebo group.
Design: Randomized clinical trial, triple-blind and placebo-controlled.
Participants: Two groups of 50 children each, aged between 5 and 59 months, not anemic or with severe malnourished, full-time assistants to two children's centres that have the same alimentation menu.
Intervention: The daily diet will be supplemented with sprinkles in one of the children's centres and will be compared anthropometric and hematological values before and after with a group receiving the same diet with placebo.
Outcome measures: Nutritional status (anthropometric measures) and haematological values (hemoglobin, ferritin, transferrin and folate).
- Conditions
- Malnutrition
- Being tested
- Sachets containing a blend of micronutrients in powder form (Iron, Zinc, Folic Acid, Vitamin A and C), sprinkled onto home made food, placebo
- Keywords
- Trace Elements, Preschool, Malnutrition, Fortified Food
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sachets containing a blend of micronutrients in powder form (Iron, Zinc, Folic Acid, Vitamin A and C), sprinkled onto home made foodDietary supplement
Also called Chispitas, Sprinkles
1 g orally on weekdays during 11 weeks
placeboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Sprinkles | Active comparator | Micronutrient Powder Sprinkles 1 gram orally on weekdays during 11 weeks Receives: Dietary Supplement: Sachets containing a blend of micronutrients in powder form (Iron, Zinc, Folic Acid, Vitamin A and C), sprinkled onto home made food |
| Placebo | Placebo comparator | Maltodextrin 1 gram orally on weekdays during 11 weeks Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin
Hemoglobin quantitation for laboratory tests (g/dl)
Measured: 10 weeks
Secondary outcomes (1)
Transferrin
Transferrin quantitation for laboratory tests (mg/dl)
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionNov 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CES University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristian Vargas G. MD, CES University
- Investigators
- Cristian Vargas, MD, Principal investigator, CES UniversityJuliana Orozco, Nutricionist, Principal investigator, CES UniversityJuliana Sánchez, Dentist, Study chair, CES UniversityLiliana Montoya, Epidemiology, Study director, CES UniversityJavier Chica, Veterinarian, Study chair, CES UniversityMaylen Rojas, Epidemiology, Study chair, CES UniversityÓscar Villada, MD, Study chair, CES UniversityAlejandro Díaz, Pediatrist, Study chair, CES University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01917032
- Sponsor's protocol ID
- SPRINK001
- Status last verified
- Aug 2013
- First submitted
- 2 Aug 2013
- Last updated
- 6 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Home-fortification With Micronutrient Powder Sprinkles in Hematologic and Nutritional Status in Preschool Children in Medellín: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT01917032
- Acronym / sponsor ID
- SPRINK001
- Conditions
- Malnutrition
- Keywords
- Trace Elements, Preschool, Malnutrition, Fortified Food
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- CES UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 6 Aug 2013 (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.
Objective: To acquire the local scientific evidence, to evaluate the effects of micronutrient Sprinkles™ powder, both the nutritional status and haematological values in the vulnerable preschool population, to corroborate the reported benefits of the experiences in other countries.
Question: Will it improve the nutritional status and hematological levels after the home fortification with Sprinkles in children of two child care centres in the city of Medellin, in 2013?
Hypothesis: At the end of intervention, hematologic levels and anthropometric indicators will be better in the intervention group with Sprinkles, compared with the placebo group.
Design: Randomized clinical trial, triple-blind and placebo-controlled.
Participants: Two groups of 50 children each, aged between 5 and 59 months, not anemic or with severe malnourished, full-time assistants to two children's centres that have the same alimentation menu.
Intervention: The daily diet will be supplemented with sprinkles in one of the children's centres and will be compared anthropometric and hematological values before and after with a group receiving the same diet with placebo.
Outcome measures: Nutritional status (anthropometric measures) and haematological values (hemoglobin, ferritin, transferrin and folate).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sprinkles | Active comparator | Dietary Supplement: Sachets containing a blend of micronutrients in powder form (Iron, Zinc, Folic Acid, Vitamin A and C), sprinkled onto home made foodMicronutrient Powder Sprinkles 1 gram orally on weekdays during 11 weeks |
| Placebo | Placebo comparator | Dietary Supplement: placeboMaltodextrin 1 gram orally on weekdays during 11 weeks |
Who may qualify
- Ages
- 5 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Assistance to children's centres full day (8 hours).
- Age 5 to 59 months.
Key exclusion criteria (4 listed)
- Anemia (hemoglobin less than 11 g / dl).
- Current supplementation with a product formulated by a health professional as a part of a nutritional recovery.
- Denial for informed consent signing by parents or legal guardians.
- Diagnosis of severe acute malnutrition by anthropometric measurements.
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 |
|---|---|---|
| Sachets containing a blend of micronutrients in powder form (Iron, Zinc, Folic Acid, Vitamin A and C), sprinkled onto home made foodAlso: Chispitas, Sprinkles1 g orally on weekdays during 11 weeks | Dietary supplement | Sprinkles |
| placebo | Dietary supplement | Placebo |
Primary outcome
Hemoglobin
Time frame: 10 weeks
Hemoglobin quantitation for laboratory tests (g/dl)
1 secondary outcome
Transferrin
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2013.
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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.
Cristian Vargas, MD principal investigator
CES University
Juliana Orozco, Nutricionist principal investigator
CES University
Juliana Sánchez, Dentist study chair
CES University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sachets containing a blend of micronutrients in powder form (Iron, Zinc, Folic Acid, Vitamin A and C), sprinkled onto home made food in people with Malnutrition, run by CES University at 1 site in Colombia.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 6 Aug 2013. 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 Colombia. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cristian Vargas, MD (573006099044, crivargas24@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2013.