Micronutrient DeficienciesNCT02101723
Effect of Sprinkles With and w/o Fe on Zn Absorption in Kenyan Toddlers
A study testing MNP + Zn/Fe and MNP + Zn in people with Micronutrient Deficiencies, run by University of Colorado, Denver at 2 sites in 2 countries.
Trial summary
The investigators propose to study the effects of increased iron intake by home fortification of complementary foods on the gastrointestinal microbial development, inflammatory responses, and zinc (Zn) absorption. Read more about this study
- Who is it for?
- Ages 5 to 10 monthsHealthy volunteers can take part
- Conditions the study is for
- Micronutrient Deficiencies
- What is being tested?
- MNP + Zn/Fe and MNP + Zn
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2011to Feb 2016
- 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 5 to 10 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Term infant
- Birthweight > 2500 g
- Healthy with no apparent congenital anomalies
- Up-to-date with vaccinations
- Hb >10 g/dL
- Breastfeeding with intent to continue for duration of study
- Negative blood slide for malaria
- Written informed consent
Who cannot join
- Acute malnutrition
- Current or anticipated used of infant formula or other fortified products
- Current or planned use of iron (or zinc) supplements
- Previous hospitalization for malaria within the last four weeks
- Persistent diarrhea
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
About this study
Official title: Effects of Sprinkles With and Without Iron on Zinc Absorption From Local Foods in Kenyan Toddlers, Including the Gut Microbiome
The investigators propose to study the effects of increased iron intake by home fortification of complementary foods on the gastrointestinal microbial development, inflammatory responses, and zinc (Zn) absorption. The proposed subjects are 9 month olds living in a malaria endemic area of rural Kenya who are randomized at 6 months of age to one of three fortificant groups: 1) Sprinkles™ with 12mg Iron(Fe)/day + other micronutrients, including 5mg/d Zn (test); Sprinkles™ with 0 mg/d Fe + other micronutrients, including 5mg/d Zn (control); Sprinkles™ with no micronutrients (placebo). The investigators hypothesize that the microbiome will be significantly different in the three groups and that Zn absorption and status, in addition to immune and oxidant status will be improved in the non-Fe fortified groups when compared to the Fe-fortified group.
Read the detailed description
Specific aims include exploration of possible mechanisms of adverse events that have been observed in iron supplementation trials in infants in malaria endemic regions by:
- Characterizing the impact of enteral iron administration on the evolution of the intestinal microbiome in infants from 6 to 9 months of age.
- Characterizing iron administration-associated inflammatory responses and correlate these with changes in the intestinal microbiome in infants from 6 to 9 months of age. Specifically, changes in the microbiome will be correlated with biomarkers reflecting:
- Intestinal inflammation;
- Systemic inflammation, bacterial translocation, and oxidant stress;
- Iron status and homeostasis
- Quantify to what degree Fe interferes with Zn absorption (TAZ) and how it affects the size of the infant's exchangeable zinc pool (EZP).
- Conditions
- Micronutrient Deficiencies
- Being tested
- MNP + Zn/Fe, MNP + Zn, Placebo
- Keywords
- Zinc absorption, Micronutrient supplement, Microbiome, Kenya, Complementary foods, Home fortification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MNP + Zn/FeDietary supplement
Micronutrient powder with 12 mg Fe and 5 mg Zn provided daily from 6-9 months of age
MNP + ZnDietary supplement
Micronutrient powder with 5 mg Zn provided daily from 6-9 months of age
PlaceboDietary supplement
Placebo powder without micronutrients
| Study group | Role | What they receive |
|---|---|---|
| Micronutrient Powder (MNP) + Zn/Fe | Active comparator | Micronutrient Powder with 5 mg Zn and 12 mg Fe Receives: Dietary Supplement: MNP + Zn/Fe |
| MNP + Zn | Active comparator | Micronutrient Powder with 5 mg Zn Receives: Dietary Supplement: MNP + Zn |
| Control | Placebo comparator | Placebo sachets without micronutrients Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in GI microbiome
Identify and quantify the phylogenic distribution of bacterial genera in the infants from 6 to 9 months in prevalence or abundance with iron supplementation at baseline, mid-point and 9 months.
Measured: 6 and 9 months of age
Secondary outcomes (5)
Change in Biomarkers of intestinal and system inflammation
Compare mean baseline and 9 month values biomarkers of intestinal and systemic inflammation and look at differences among the 3 groups.
Measured: 6 and 9 months of age
Absorption of Zn
Determine the effects of increased iron intake on zinc absorption from micronutrient powder added to local complementary foods of Kenyan toddlers in a malaria-endemic area.
Measured: 9 months of age
Size of exchangeable Zn pool
Determine the effect of increase iron intake on size of exchangeable Zn pool (EZP) after 3 months of home fortification with micronutrient powder in maize-based diets in rural Kenyan infants.
Measured: 9 months of age
Change in Biomarkers of bacterial translocation
To compare biomarkers of bacterial translocation among the 3 groups and look at longitudinal differences between 6 and 9 mo of age.
Measured: 6 and 9 mo of age
Change in Biomarkers of oxidative stress
Compare biomarkers of oxidative stress among the 3 groups and look at longitudinal differences at 6 and 9 mo of age.
Measured: 6 and 9 mo of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study startApr 2011
- Primary completionJan 2013
- Study completionFeb 2016
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 Micronutrient DeficienciesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), International Atomic Energy Agency, Moi University
- Responsible party
- Sponsor
- Investigators
- Nancy F Krebs, MD, Principal investigator, University of Colorado, DenverFabian Esamai, MD, Study director, Moi Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02101723
- Sponsor's protocol ID
- 11-0227
- Other IDs
- K24DK083772, 15827, 16933
- Status last verified
- May 2018
- First submitted
- 28 Mar 2014
- Last updated
- 21 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Esamai F, Liechty E, Ikemeri J, Westcott J, Kemp J, Culbertson D, Miller LV, Hambidge KM, Krebs NF. Zinc absorption from micronutrient powder is low but is not affected by iron in Kenyan infants. Nutrients. 2014 Dec;6(12):5636-51. doi: 10.3390/nu6125636.
PubMed 25493942
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sprinkles With and Without Iron on Zinc Absorption From Local Foods in Kenyan Toddlers, Including the Gut Microbiome
- ClinicalTrials.gov ID
- NCT02101723
- Acronym / sponsor ID
- 11-0227
- Conditions
- Micronutrient Deficiencies
- Keywords
- Zinc absorption, Micronutrient supplement, Microbiome, Kenya, Complementary foods, Home fortification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), International Atomic Energy Agency, Moi University
- Study start
- Apr 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 2 Apr 2014 (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.
The investigators propose to study the effects of increased iron intake by home fortification of complementary foods on the gastrointestinal microbial development, inflammatory responses, and zinc (Zn) absorption. The proposed subjects are 9 month olds living in a malaria endemic area of rural Kenya who are randomized at 6 months of age to one of three fortificant groups: 1) Sprinkles™ with 12mg Iron(Fe)/day + other micronutrients, including 5mg/d Zn (test); Sprinkles™ with 0 mg/d Fe + other micronutrients, including 5mg/d Zn (control); Sprinkles™ with no micronutrients (placebo). The investigators hypothesize that the microbiome will be significantly different in the three groups and that Zn absorption and status, in addition to immune and oxidant status will be improved in the non-Fe fortified groups when compared to the Fe-fortified group.
Detailed description
Specific aims include exploration of possible mechanisms of adverse events that have been observed in iron supplementation trials in infants in malaria endemic regions by:
- Characterizing the impact of enteral iron administration on the evolution of the intestinal microbiome in infants from 6 to 9 months of age.
- Characterizing iron administration-associated inflammatory responses and correlate these with changes in the intestinal microbiome in infants from 6 to 9 months of age. Specifically, changes in the microbiome will be correlated with biomarkers reflecting:
- Intestinal inflammation;
- Systemic inflammation, bacterial translocation, and oxidant stress;
- Iron status and homeostasis
- Quantify to what degree Fe interferes with Zn absorption (TAZ) and how it affects the size of the infant's exchangeable zinc pool (EZP).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Micronutrient Powder (MNP) + Zn/Fe | Active comparator | Dietary Supplement: MNP + Zn/FeMicronutrient Powder with 5 mg Zn and 12 mg Fe |
| MNP + Zn | Active comparator | Dietary Supplement: MNP + ZnMicronutrient Powder with 5 mg Zn |
| Control | Placebo comparator | Dietary Supplement: PlaceboPlacebo sachets without micronutrients |
Who may qualify
- Ages
- 5 to 10 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Term infant
- Birthweight > 2500 g
- Healthy with no apparent congenital anomalies
- Up-to-date with vaccinations
- Hb >10 g/dL
Key exclusion criteria (5 listed)
- Acute malnutrition
- Current or anticipated used of infant formula or other fortified products
- Current or planned use of iron (or zinc) supplements
- Previous hospitalization for malaria within the last four weeks
- Persistent diarrhea
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 |
|---|---|---|
| MNP + Zn/FeMicronutrient powder with 12 mg Fe and 5 mg Zn provided daily from 6-9 months of age | Dietary supplement | Micronutrient Powder (MNP) + Zn/Fe |
| MNP + ZnMicronutrient powder with 5 mg Zn provided daily from 6-9 months of age | Dietary supplement | MNP + Zn |
| PlaceboPlacebo powder without micronutrients | Dietary supplement | Control |
Primary outcome
Changes in GI microbiome
Time frame: 6 and 9 months of age
Identify and quantify the phylogenic distribution of bacterial genera in the infants from 6 to 9 months in prevalence or abundance with iron supplementation at baseline, mid-point and 9 months.
5 secondary outcomes
Change in Biomarkers of intestinal and system inflammation
Time frame: 6 and 9 months of age
Absorption of Zn
Time frame: 9 months of age
Size of exchangeable Zn pool
Time frame: 9 months of age
Change in Biomarkers of bacterial translocation
Time frame: 6 and 9 mo of age
Change in Biomarkers of oxidative stress
Time frame: 6 and 9 mo of age
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 21 May 2018.
- Background: PubMed 25493942Esamai F, Liechty E, Ikemeri J, Westcott J, Kemp J, Culbertson D, Miller LV, Hambidge KM, Krebs NF. Zinc absorption from micronutrient powder is low but is not affected by iron in Kenyan infants. Nutrients. 2014 Dec;6(12):5636-51. doi: 10.3390/nu6125636.
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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.
Nancy F Krebs, MD principal investigator
University of Colorado, Denver
Fabian Esamai, MD study director
Moi Univeristy
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MNP + Zn/Fe and MNP + Zn in people with Micronutrient Deficiencies, run by University of Colorado, Denver at 2 sites in 2 countries.
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 8 inclusion and 5 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 21 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Kenya. 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?
Changes in GI microbiome (time frame: 6 and 9 months of age). 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 NCT02101723, 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 21 May 2018.