Iron AbsorptionNCT04774016
Iron Absorption From an Iron-fortified Follow-up Formula With Added Synbiotic or Human Milk Oligosaccharides
A study testing Test formula A without added pre- and pro-biotic, Test formula B with synbiotic and Test formula C with HMOs in people with Iron Absorption, run by Société des Produits Nestlé (SPN) at 1 site in Thailand.
Trial summary
The co-primary objectives of this study are: 1) to investigate the effect adding a synbiotic (combination of a pre-and probiotic) to iron-fortified follow-up formula (FUF) on iron bioavailability, and 2) to investigate the effect adding Human Milk Oligosaccharides (HMOs) to iron-fortified FUF on iron bioavailability… Read more about this study
- Who is it for?
- Ages 40 to 56 weeksHealthy volunteers can take part
- Conditions the study is for
- Iron Absorption
- What is being tested?
- Test formula A without added pre- and pro-biotic, Test formula B with synbiotic and Test formula C with HMOs
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteThailand
- Study dates
- 18 Nov 2020to 7 Jun 2021
- 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 40 to 56 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Written informed consent has been obtained from the parents/legally acceptable representative
- Child aged 40-56 weeks (± 3 weeks)
- Child exhibits no clinical signs/symptoms of chronic disease or acute illness
- Capillary Hb ≥70 g/L
- Anticipated residence in the area for the study duration
- Z-scores for weight-for-age and weight-for-length both >-3, if the infant is severely underweight or severely malnourished.
- Singleton, full-term gestation birth (≥37 weeks)
- Birth weight ≥2.5 kg and ≤4.5 kg
Who cannot join
- Child exhibits clinical signs/symptoms of chronic infectious, metabolic, genetic illness or other disease including any condition that impacts feeding or growth
- Child received vitamin and mineral supplements in the 2 weeks prior to enrollment
- Child is exclusively breastfed
- Child received antibiotic treatments in the 4 weeks prior to enrollment
- Parents or caretakers not willing/not able to comply with the requirements of the study protocol
- Child has allergy or intolerance to cows' milk protein or lactose, or severe food allergies
- Child is participating in any other interventional clinical trial that would interfere with study outcomes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Iron Absorption From an Iron-fortified Follow-up Formula With and Without the Addition of a Synbiotic or Human Milk Oligosaccharides: a Stable Isotope Study in 10-14 Month-old Thai Children
The co-primary objectives of this study are: 1) to investigate the effect adding a synbiotic (combination of a pre-and probiotic) to iron-fortified follow-up formula (FUF) on iron bioavailability, and 2) to investigate the effect adding Human Milk Oligosaccharides (HMOs) to iron-fortified FUF on iron bioavailability in 10-14 month-old Thai children.
Read the detailed description
Iron stores of healthy, full-term neonates are supposed to cover iron needs for the first 4-6 months of life. After 6 months of age, requirements for absorbed iron are high, as infants need to build body iron stores and triple their body weight before the first year of life. Iron concentrations in mature breastmilk are low (~0.3 mg/L) and cannot adequately cover the high iron requirements of children between 6 and 24 months of age. Follow-up formulas (FUF) are fortified milk-based products intended for infants above 6 months of age and young children aged 1-3 years, and are widely used as a liquid part of the weaning diet to supplement the diet of young children with macro- and micronutrients. Prebiotics and probiotics are increasingly added to foods for infants and young children due to emerging evidence on possible health benefits. We recently showed that the addition of prebiotic galacto-oligosaccharides (GOS) to an iron-containing micronutrient powder increased iron absorption in Kenyan infants. To our knowledge, the effect of the combination of pre- and probiotics (synbiotic) or human milk oligosaccharides (HMOs) on iron absorption from an iron-fortified FUF has not been investigated.
Thai children (10-14 months old) will be assigned to receive FUF fortified with isotopically labelled iron as FeSO4 1) with synbiotic, 2) HMO, and 3) without added prebiotics as a reference, in random order. Besides the iron source and synbiotic or HMO, the test FUF will be identical in terms of macro- and micronutrient composition. For the secondary objectives of this study, which will have a single-group, before-after design, each infant will receive the test FUF with added synbiotic for 25 days on gut comfort and quality of life outcomes.
- Conditions
- Iron Absorption
- Being tested
- Test formula A without added pre- and pro-biotic, Test formula B with synbiotic, Test formula C with HMOs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test formula A without added pre- and pro-bioticOther
An identical formula as test formulas fortified with 2.20 mg iron as FeSO4-58 and 0.05 mg native iron per serving (235 ml), but without added pre- or probiotic.
Test formula B with synbioticOther
Test formula fortified with 2.20 mg iron as FeSO4-57 and 0.05 mg native iron per serving (235 ml) and added synbiotic.
Test formula C with HMOsOther
Test formula fortified with 2.20 mg iron as FeSO4-54 and 0.05 mg native iron per serving (235 ml) and added HMOs.
| Study group | Role | What they receive |
|---|---|---|
| Test formula C | Experimental | Not described Receives: Other: Test formula C with HMOs |
| Test formula B | Experimental | Not described Receives: Other: Test formula B with synbiotic |
| Test formula A | Placebo comparator | Not described Receives: Other: Test formula A without added pre- and pro-biotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional Iron Absorption (FIA) from an iron-fortified follow-up infant formula with and without the addition of a synbiotic
FIA from test formulas will be determined based on the shift of the iron isotope ratios in whole blood.
Measured: Measured 28 days after administration of last test formula
Fractional Iron Absorption (FIA) from an iron-fortified follow-up infant formula with and without the addition of a synbiotic
FIA from test formulas will be determined based on the shift of the iron isotope ratios in whole blood.
Measured: Measured 14 days after administration of last test formula
FIA from an iron-fortified follow-up formula with and without the addition of human oligosaccharides (HMOs)
FIA from test formulas will be determined based on the shift of the iron isotope ratios in whole blood.
Measured: Measured 28 days after administration of last test formula
FIA from an iron-fortified follow-up formula with and without the addition of human oligosaccharides (HMOs)
FIA from test formulas will be determined based on the shift of the iron isotope ratios in whole blood.
Measured: Measured 14 days after administration of last test formula
Secondary outcomes (12)
Effects of feeding an iron-fortified FUF with added synbiotic (Formula B) for 25 days on Iron status (haemoglobin [Hb])
Change in iron status biomarkers (Hb) from baseline until last study visit (day 40)
Measured: At baseline and last study visit (day 40)
Effects of feeding an iron-fortified FUF with added synbiotic (Formula B) for 25 days on Iron status (plasma ferritin [PF])
Change in iron status biomarkers (PF) from baseline until last study visit (day 40)
Measured: At baseline and last study visit (day 40)
Effects of feeding an iron-fortified FUF with added synbiotic (Formula B) for 25 days on Iron status (soluble transferrin receptor [sTfR])
Change in iron status biomarkers (sTfR) from baseline until last study visit (day 40)
Measured: At baseline and last study visit (day 40)
Effects of feeding an iron-fortified FUF with added synbiotic (Formula B) for 25 days on inflammation status ((C-reactive protein [CRP])
Change in CRP from baseline until last study visit (day 40)
Measured: At baseline and last study visit (day 40)
Effects of feeding an iron-fortified FUF with added synbiotic (Formula B) for 25 days on inflammation status (alpha-1-acid glycoprotein [AGP]))
Change in AGP from baseline until last study visit (day 40)
Measured: At baseline and last study visit (day 40)
Effects of feeding an iron-fortified FUF with added synbiotic (Formula B) for 25 days on gastrointestinal (GI) tolerance
Change in GI tolerance based on caregiver-reported stool frequency (number of stools per day), consistency (on a scale from watery, runny, mushy soft, formed soft, hard, and difficult-to-pass stools (yes/no) from baseline until last study visit (day 40)
Measured: At baseline and last study visit (day 40)
Effects of feeding an iron-fortified FUF with added synbiotic (Formula B) for 25 days on gut comfort
Change in gut comfort based on Gut Comfort Questionnaire to assess overall GI burden and individual GI symptoms/GI-related behaviours from baseline until last study visit (day 40)
Measured: At baseline and last study visit (day 40)
Effects of feeding an iron-fortified FUF with added synbiotic (Formula B) for 25 days on health-related quality of life
Change in health-related quality of life, assessed by validated Infant and Toddler Quality of Life questionnaire from baseline until last study visit (day 40)
Measured: At baseline and last study visit (day 40)
Effect of feeding an iron-fortified FUF with added synbiotic (Formula B) for 25 days on gut microbiota composition and diversity
Change in gut microbiota composition and diversity between baseline and last study visit (day 40)
Measured: At baseline and last study visit (day 40)
Effect of feeding an iron-fortified FUF with added synbiotic (Formula B) for 25 days on fecal pH
Change in fecal pH between baseline and last study visit (day 40)
Measured: At baseline and last study visit (day 40)
Effect of feeding an iron-fortified FUF with added synbiotic (Formula B) for 25 days on gut inflammation
Change in gut inflammation marker (calprotectin) between baseline and last study visit (day 40)
Measured: At baseline and last study visit (day 40)
Effect of feeding an iron-fortified FUF with added synbiotic (Formula B) for 25 days on gut integrity
Change in gut integrity marker (serum intestinal fatty acid binding protein [I-FABP]) between baseline and last study visit (day 40)
Measured: At baseline and last study visit (day 40)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start18 Nov 2020
- Primary completion23 Mar 2021
- Study completion7 Jun 2021
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 Iron AbsorptionStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04774016
- Sponsor's protocol ID
- 18.15.INF
- Status last verified
- Mar 2023
- First submitted
- 17 Dec 2020
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Scheuchzer P, Sinawat S, Donze AS, Zeder C, Sabatier M, Garcia-Garcera M, Ricci C, Kamontham T, Zimmermann MB, Baumgartner J. Iron Absorption from an Iron-Fortified Follow-Up Formula with and without the Addition of a Synbiotic or a Human-Identical Milk Oligosaccharide: A Randomized Crossover Stable Isotope Study in Young Thai Children. J Nutr. 2024 Oct;154(10):2988-2998. doi: 10.1016/j.tjnut.2024.08.016. Epub 2024 Aug 22.
PubMed 39179207
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Absorption From an Iron-fortified Follow-up Formula With and Without the Addition of a Synbiotic or Human Milk Oligosaccharides: a Stable Isotope Study in 10-14 Month-old Thai Children
- ClinicalTrials.gov ID
- NCT04774016
- Acronym / sponsor ID
- 18.15.INF
- Conditions
- Iron Absorption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 18 Nov 2020 (actual)
- Primary completion
- 23 Mar 2021 (actual)
- Study completion
- 7 Jun 2021 (actual)
- First posted
- 26 Feb 2021 (actual)
- 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 co-primary objectives of this study are: 1) to investigate the effect adding a synbiotic (combination of a pre-and probiotic) to iron-fortified follow-up formula (FUF) on iron bioavailability, and 2) to investigate the effect adding Human Milk Oligosaccharides (HMOs) to iron-fortified FUF on iron bioavailability in 10-14 month-old Thai children.
Detailed description
Iron stores of healthy, full-term neonates are supposed to cover iron needs for the first 4-6 months of life. After 6 months of age, requirements for absorbed iron are high, as infants need to build body iron stores and triple their body weight before the first year of life. Iron concentrations in mature breastmilk are low (~0.3 mg/L) and cannot adequately cover the high iron requirements of children between 6 and 24 months of age. Follow-up formulas (FUF) are fortified milk-based products intended for infants above 6 months of age and young children aged 1-3 years, and are widely used as a liquid part of the weaning diet to supplement the diet of young children with macro- and micronutrients. Prebiotics and probiotics are increasingly added to foods for infants and young children due to emerging evidence on possible health benefits. We recently showed that the addition of prebiotic galacto-oligosaccharides (GOS) to an iron-containing micronutrient powder increased iron absorption in Kenyan infants. To our knowledge, the effect of the combination of pre- and probiotics (synbiotic) or human milk oligosaccharides (HMOs) on iron absorption from an iron-fortified FUF has not been investigated.
Thai children (10-14 months old) will be assigned to receive FUF fortified with isotopically labelled iron as FeSO4 1) with synbiotic, 2) HMO, and 3) without added prebiotics as a reference, in random order. Besides the iron source and synbiotic or HMO, the test FUF will be identical in terms of macro- and micronutrient composition. For the secondary objectives of this study, which will have a single-group, before-after design, each infant will receive the test FUF with added synbiotic for 25 days on gut comfort and quality of life outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test formula C | Experimental | Other: Test formula C with HMOs |
| Test formula B | Experimental | Other: Test formula B with synbiotic |
| Test formula A | Placebo comparator | Other: Test formula A without added pre- and pro-biotic |
Who may qualify
- Ages
- 40 to 56 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Written informed consent has been obtained from the parents/legally acceptable representative
- Child aged 40-56 weeks (± 3 weeks)
- Child exhibits no clinical signs/symptoms of chronic disease or acute illness
- Capillary Hb ≥70 g/L
- Anticipated residence in the area for the study duration
Key exclusion criteria (7 listed)
- Child exhibits clinical signs/symptoms of chronic infectious, metabolic, genetic illness or other disease including any condition that impacts feeding or growth
- Child received vitamin and mineral supplements in the 2 weeks prior to enrollment
- Child is exclusively breastfed
- Child received antibiotic treatments in the 4 weeks prior to enrollment
- Parents or caretakers not willing/not able to comply with the requirements of the study 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 |
|---|---|---|
| Test formula A without added pre- and pro-bioticAn identical formula as test formulas fortified with 2.20 mg iron as FeSO4-58 and 0.05 mg native iron per serving (235 ml), but without added pre- or probiotic. | Other | Test formula A |
| Test formula B with synbioticTest formula fortified with 2.20 mg iron as FeSO4-57 and 0.05 mg native iron per serving (235 ml) and added synbiotic. | Other | Test formula B |
| Test formula C with HMOsTest formula fortified with 2.20 mg iron as FeSO4-54 and 0.05 mg native iron per serving (235 ml) and added HMOs. | Other | Test formula C |
Primary outcome
Fractional Iron Absorption (FIA) from an iron-fortified follow-up infant formula with and without the addition of a synbiotic
Time frame: Measured 28 days after administration of last test formula
FIA from test formulas will be determined based on the shift of the iron isotope ratios in whole blood.
Fractional Iron Absorption (FIA) from an iron-fortified follow-up infant formula with and without the addition of a synbiotic
Time frame: Measured 14 days after administration of last test formula
FIA from test formulas will be determined based on the shift of the iron isotope ratios in whole blood.
FIA from an iron-fortified follow-up formula with and without the addition of human oligosaccharides (HMOs)
Time frame: Measured 28 days after administration of last test formula
FIA from test formulas will be determined based on the shift of the iron isotope ratios in whole blood.
FIA from an iron-fortified follow-up formula with and without the addition of human oligosaccharides (HMOs)
Time frame: Measured 14 days after administration of last test formula
FIA from test formulas will be determined based on the shift of the iron isotope ratios in whole blood.
12 secondary outcomes
Effects of feeding an iron-fortified FUF with added synbiotic (Formula B) for 25 days on Iron status (haemoglobin [Hb])
Time frame: At baseline and last study visit (day 40)
Effects of feeding an iron-fortified FUF with added synbiotic (Formula B) for 25 days on Iron status (plasma ferritin [PF])
Time frame: At baseline and last study visit (day 40)
Effects of feeding an iron-fortified FUF with added synbiotic (Formula B) for 25 days on Iron status (soluble transferrin receptor [sTfR])
Time frame: At baseline and last study visit (day 40)
Effects of feeding an iron-fortified FUF with added synbiotic (Formula B) for 25 days on inflammation status ((C-reactive protein [CRP])
Time frame: At baseline and last study visit (day 40)
Effects of feeding an iron-fortified FUF with added synbiotic (Formula B) for 25 days on inflammation status (alpha-1-acid glycoprotein [AGP]))
Time frame: At baseline and last study visit (day 40)
Effects of feeding an iron-fortified FUF with added synbiotic (Formula B) for 25 days on gastrointestinal (GI) tolerance
Time frame: At baseline and last study visit (day 40)
Effects of feeding an iron-fortified FUF with added synbiotic (Formula B) for 25 days on gut comfort
Time frame: At baseline and last study visit (day 40)
Effects of feeding an iron-fortified FUF with added synbiotic (Formula B) for 25 days on health-related quality of life
Time frame: At baseline and last study visit (day 40)
Effect of feeding an iron-fortified FUF with added synbiotic (Formula B) for 25 days on gut microbiota composition and diversity
Time frame: At baseline and last study visit (day 40)
Effect of feeding an iron-fortified FUF with added synbiotic (Formula B) for 25 days on fecal pH
Time frame: At baseline and last study visit (day 40)
Effect of feeding an iron-fortified FUF with added synbiotic (Formula B) for 25 days on gut inflammation
Time frame: At baseline and last study visit (day 40)
Effect of feeding an iron-fortified FUF with added synbiotic (Formula B) for 25 days on gut integrity
Time frame: At baseline and last study visit (day 40)
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 24 Mar 2023.
- Derived from this study: PubMed 39179207Scheuchzer P, Sinawat S, Donze AS, Zeder C, Sabatier M, Garcia-Garcera M, Ricci C, Kamontham T, Zimmermann MB, Baumgartner J. Iron Absorption from an Iron-Fortified Follow-Up Formula with and without the Addition of a Synbiotic or a Human-Identical Milk Oligosaccharide: A Randomized Crossover Stable Isotope Study in Young Thai Children. J Nutr. 2024 Oct;154(10):2988-2998. doi: 10.1016/j.tjnut.2024.08.016. Epub 2024 Aug 22.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test formula A without added pre- and pro-biotic, Test formula B with synbiotic and Test formula C with HMOs in people with Iron Absorption, run by Société des Produits Nestlé (SPN) at 1 site in Thailand.
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 7 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 24 Mar 2023. 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 Thailand. 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?
Fractional Iron Absorption (FIA) from an iron-fortified follow-up infant formula with and without the addition of a synbiotic (time frame: Measured 28 days after administration of last test formula). The study lists 4 primary outcomes in all. 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 NCT04774016, 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 24 Mar 2023.