Bacterial InfectionsNCT01111864
Changes in Microbiota and Iron Status After Iron Fortification of Complementary Foods
A study testing fortification with iron and micronutrients and Sprinkles in people with Bacterial Infections, run by Swiss Federal Institute of Technology at 1 site in Kenya.
Trial summary
Infants and children under two years are the group with the highest rates of iron deficiency anemia. Provision of sufficient dietary iron to this age group is a challenge, and in-home iron fortification of complementary foods using micronutrient powders can be an effective approach. Read more about this study
- Who is it for?
- Ages 24 to 28 weeks
- Conditions the study is for
- Bacterial Infections
- What is being tested?
- fortification with iron and micronutrients and Sprinkles
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteKenya
- Study dates
- Feb 2010to Oct 2012
- 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 24 to 28 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Mother at least ≥15 years of age, infants 5.5- 6.5 months
- Willingness to provide informed consent
- Apparent good health
- Long-term residence in study site and anticipating residing in the area for at least 3 years
- Speak a Mjikenda language or Kiswahili in the home
- Willingness to provide blood samples during clinic visits
Who cannot join
- Hemoglobin <70 g/L for infants; these infants will be referred for treatment at the local health clinic/hospital.
- Acute or chronic pulmonary, cardiovascular, hepatic, renal or neurological condition or any other finding that in the opinion of the PI or co-researchers that would increase risk of participating in the study.
- Other conditions that in the opinion of the PI or co-researchers would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Iron Fortification of Complementary Foods on Iron Status and Infant Gut Microbiota in Kenya
Infants and children under two years are the group with the highest rates of iron deficiency anemia. Provision of sufficient dietary iron to this age group is a challenge, and in-home iron fortification of complementary foods using micronutrient powders can be an effective approach. However, WHO has recently cautioned against untargeted use of in-home micronutrient powders that contain the entire iron RDA for a child in a single dose in areas with high rates of infections from malaria and diarrheal disease. Therefore, in this study, we will investigate the effect on the infant gut microbiota of a low dose (ca. 25% of the RDA) of highly bioavailable iron, provided by a micronutrient powder added to a complementary food.
The study aim is to determine if in-home fortification using an iron-containing micronutrient powder in Kenyan infants will improve iron status and/or modify the composition and metabolic activity of the gut microbiota. Active surveillance will be done weekly to monitor the health of the infants.
Our study will be done in a subgroup (n=160) of a larger double-blind controlled feeding trial in which 330 infants will be randomized to receive a micronutrient powder containing either 2.5 mg iron or no iron for 1 year. In our substudy, the infants will be studied only over the first 6 months of the 1 year intervention. Blood samples, taken at baseline and after 6 months will be used to define the iron status and the anemia level of the infants. Stool samples (2 at baseline before intervention, 6 throughout the study and additional samples in case of diarrhea) will be obtained for analysis of the gut microbiota. In the entire study (n=330), we will measure changes in iron status over 1 year.
- Conditions
- Bacterial Infections
- Being tested
- fortification with iron and micronutrients, Sprinkles
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fortification with iron and micronutrientsDietary supplement
Iron 0 or 2.5 mg; Copper 0.34 mg; 30 µg Iodine; 7 µg Selenium; 2.5 mg Zinc; 100 µg Vitamin A; Vitamin D 5 µg; 5 mg Tocopherol Equivalent; 30 µg Vitamin K1; 10.5 mg Thiamine; 0.5 mg Riboflavin; 0.5 mg Pyridoxine; 90 µg Folic Acid Anhydrous; 6 mg Niacinamide; 60 mg Vitamin C; 0.9 µg Vitamin B12
SprinklesDietary supplement
Daily 12.5mg Ferrous fumarate iron with microntrient is compared to no iron with micronutrients. Duration of intervention is 4 months, 80 infants will be inclulded.
| Study group | Role | What they receive |
|---|---|---|
| MixMe powder (iron & micronutrients) | Experimental | Not described Receives: Dietary Supplement: fortification with iron and micronutrients |
| MixMe powder (micronutrients, no iron) | Placebo comparator | Not described Receives: Dietary Supplement: fortification with iron and micronutrients |
| Sprinkles (iron and micronutrients) | Experimental | Vitamin A 300 µg; Vitamin C 30 mg; Folic Acid 160 µg; Iron 12.5 mg; Zinc 5 mg Receives: Dietary Supplement: Sprinkles |
| Sprinkles (micronutrients, no iron) | Placebo comparator | Vitamin A 300 µg; Vitamin C 30 mg; Folic Acid 160 µg; Zinc 5 mg Receives: Dietary Supplement: Sprinkles |
What is being measured
The primary outcome is the main question the study is designed to answer.
gut microbiota composition
Changes in gut microbiota composition
Measured: Fecal sample after 2 months
Secondary outcomes (1)
iron status
Efficacy of iron fortification in complementary foods
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2010 (estimated)
- Study startFeb 2010
- Primary completionSep 2012
- Study completionOct 2012
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 Bacterial InfectionsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- University of KwaZulu, University of Nairobi
- Responsible party
- Principal investigator, Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
- Investigators
- Michael B Zimmermann, M.D., Study director, Human Nutrition Laboratory, Swiss Federal Institute of TechnologyJane Kvalsvig, PhD, Principal investigator, Department of Public Health Medicine, Nelson Mandela School of Medicine, South Africa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01111864
- Sponsor's protocol ID
- 2-cercamondi
- Status last verified
- Jun 2013
- First submitted
- 23 Apr 2010
- Last updated
- 7 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jaeggi T, Kortman GA, Moretti D, Chassard C, Holding P, Dostal A, Boekhorst J, Timmerman HM, Swinkels DW, Tjalsma H, Njenga J, Mwangi A, Kvalsvig J, Lacroix C, Zimmermann MB. Iron fortification adversely affects the gut microbiome, increases pathogen abundance and induces intestinal inflammation in Kenyan infants. Gut. 2015 May;64(5):731-42. doi: 10.1136/gutjnl-2014-307720. Epub 2014 Aug 20.
PubMed 25143342
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Iron Fortification of Complementary Foods on Iron Status and Infant Gut Microbiota in Kenya
- ClinicalTrials.gov ID
- NCT01111864
- Acronym / sponsor ID
- 2-cercamondi
- Conditions
- Bacterial Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- University of KwaZulu, University of Nairobi
- Study start
- Feb 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 28 Apr 2010 (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.
Infants and children under two years are the group with the highest rates of iron deficiency anemia. Provision of sufficient dietary iron to this age group is a challenge, and in-home iron fortification of complementary foods using micronutrient powders can be an effective approach. However, WHO has recently cautioned against untargeted use of in-home micronutrient powders that contain the entire iron RDA for a child in a single dose in areas with high rates of infections from malaria and diarrheal disease. Therefore, in this study, we will investigate the effect on the infant gut microbiota of a low dose (ca. 25% of the RDA) of highly bioavailable iron, provided by a micronutrient powder added to a complementary food.
The study aim is to determine if in-home fortification using an iron-containing micronutrient powder in Kenyan infants will improve iron status and/or modify the composition and metabolic activity of the gut microbiota. Active surveillance will be done weekly to monitor the health of the infants.
Our study will be done in a subgroup (n=160) of a larger double-blind controlled feeding trial in which 330 infants will be randomized to receive a micronutrient powder containing either 2.5 mg iron or no iron for 1 year. In our substudy, the infants will be studied only over the first 6 months of the 1 year intervention. Blood samples, taken at baseline and after 6 months will be used to define the iron status and the anemia level of the infants. Stool samples (2 at baseline before intervention, 6 throughout the study and additional samples in case of diarrhea) will be obtained for analysis of the gut microbiota. In the entire study (n=330), we will measure changes in iron status over 1 year.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MixMe powder (iron & micronutrients) | Experimental | Dietary Supplement: fortification with iron and micronutrients |
| MixMe powder (micronutrients, no iron) | Placebo comparator | Dietary Supplement: fortification with iron and micronutrients |
| Sprinkles (iron and micronutrients) | Experimental | Dietary Supplement: SprinklesVitamin A 300 µg; Vitamin C 30 mg; Folic Acid 160 µg; Iron 12.5 mg; Zinc 5 mg |
| Sprinkles (micronutrients, no iron) | Placebo comparator | Dietary Supplement: SprinklesVitamin A 300 µg; Vitamin C 30 mg; Folic Acid 160 µg; Zinc 5 mg |
Who may qualify
- Ages
- 24 to 28 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Mother at least ≥15 years of age, infants 5.5- 6.5 months
- Willingness to provide informed consent
- Apparent good health
- Long-term residence in study site and anticipating residing in the area for at least 3 years
- Speak a Mjikenda language or Kiswahili in the home
Key exclusion criteria (3 listed)
- Hemoglobin <70 g/L for infants; these infants will be referred for treatment at the local health clinic/hospital.
- Acute or chronic pulmonary, cardiovascular, hepatic, renal or neurological condition or any other finding that in the opinion of the PI or co-researchers that would increase risk of participating in the study.
- Other conditions that in the opinion of the PI or co-researchers would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol
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 |
|---|---|---|
| fortification with iron and micronutrientsIron 0 or 2.5 mg; Copper 0.34 mg; 30 µg Iodine; 7 µg Selenium; 2.5 mg Zinc; 100 µg Vitamin A; Vitamin D 5 µg; 5 mg Tocopherol Equivalent; 30 µg Vitamin K1; 10.5 mg Thiamine; 0.5 mg Riboflavin; 0.5 mg Pyridoxine; 90 µg Folic Acid Anhydrous; 6 mg Niacinamide; 60 mg Vitamin C; 0.9 µg Vitamin B12 | Dietary supplement | MixMe powder (iron & micronutrients), MixMe powder (micronutrients, no iron) |
| SprinklesDaily 12.5mg Ferrous fumarate iron with microntrient is compared to no iron with micronutrients. Duration of intervention is 4 months, 80 infants will be inclulded. | Dietary supplement | Sprinkles (iron and micronutrients), Sprinkles (micronutrients, no iron) |
Primary outcome
gut microbiota composition
Time frame: Fecal sample after 2 months
Changes in gut microbiota composition
1 secondary outcome
iron status
Time frame: 12 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 7 Jun 2013.
- Derived from this study: PubMed 25143342Jaeggi T, Kortman GA, Moretti D, Chassard C, Holding P, Dostal A, Boekhorst J, Timmerman HM, Swinkels DW, Tjalsma H, Njenga J, Mwangi A, Kvalsvig J, Lacroix C, Zimmermann MB. Iron fortification adversely affects the gut microbiome, increases pathogen abundance and induces intestinal inflammation in Kenyan infants. Gut. 2015 May;64(5):731-42. doi: 10.1136/gutjnl-2014-307720. Epub 2014 Aug 20.
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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.
Michael B Zimmermann, M.D. study director
Human Nutrition Laboratory, Swiss Federal Institute of Technology
Jane Kvalsvig, PhD principal investigator
Department of Public Health Medicine, Nelson Mandela School of Medicine, South Africa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fortification with iron and micronutrients and Sprinkles in people with Bacterial Infections, run by Swiss Federal Institute of Technology at 1 site in Kenya.
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 6 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 7 Jun 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 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?
gut microbiota composition (time frame: Fecal sample after 2 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 NCT01111864, 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 7 Jun 2013.