Iron Absorption From a Micronutrient Powder Containing Galacto-oligosaccharides (GOS)

NCT02666417 | Completed DMC

• 1 other identifier: FeGOS_KP
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Infants and young children in sub-Saharan Africa have high rates of iron deficiency anemia (IDA), which adversely affects their growth and cognitive development. In-home iron fortification of complementary foods using micronutrient powders (MNPs) reduces risk for IDA. However, in areas with a high burden of infectious diseases iron may increase the risk of unfavorable gut microbiota composition possibly influencing diarrhea prevalence. Thus, there is an urgent need to find safer formulations of iron fortification for African infants. The investigators recently finished a randomized, double blind controlled intervention trial in Kenya where the investigators tested whether the addition of galacto-oligosaccharides (GOS) in a MNP containing 5 mg of iron protects against the adverse effects of the iron on the infant gut microbiome and gut inflammation (ClincalTrails.gov Identifier: NCT02118402). Prebiotics are also potential enhancers of colonic iron absorption. Therefore, to complement the intervention study, the present study will compare iron absorption from the combination of sodium iron EDTA (NaFeEDTA) and ferrous fumarate (FeFum) with and without prior consumption GOS or 3 weeks. The investigators will enroll 80 Kenyan infants from Kwale County, aged 6-14 months of whom 40 infants will consume maize porridge blended with MNP containing iron and 40 infants will receive a porridge mixed with MNP containing iron+GOS. After 3 weeks of MNP consumption, two test meals will be fed on two consecutive mornings, and will consist of maize porridge containing isotopically labeled FeFum and NaFeEDTA or isotopically labeled ferrous sulfate (FeSO₄), respectively. Fourteen days after the second test meal administration, a whole blood sample will be collected by venipuncture for iron isotopic analysis. Iron and inflammation status parameter will be determined at baseline and endpoint. A stool sample will be collected at baseline and on the first test meal day. The gut microbiome, fecal pH and fecal SCFAs profile will be analyzed. Knowing the expected iron absorption from the iron and GOS containing MNP will inform decisions on type of iron compound and dosing regimens for MNPs to allow the lowest iron dose to be used but still cover the infant requirement for absorbed iron.

Conditions

Anemia, Iron-Deficiency

Keywords

Iron fortification; Anemia; Iron Deficiency; Iron Absorption; Prebiotics; Stable isotopes

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the isotopic ratio of iron in blood at week 5

  The change in the isotopic ratio of iron will be measured after the administration of test meals including iron isotopes.

  Baseline and Week 5

Secondary Outcomes (4)

• Gut microbiome composition

  Baseline and Week 3

• Fecal pH

  Baseline and Week 3

• Fecal short chain fatty acids (SCFAs)

  Baseline and Week 3

• H.pylori

  Baseline

Study Arms (2)

MNP+iron and test meal

ACTIVE COMPARATOR

The MNP contains 400 μg Vitamin A, 5 μgVitamin D, 5 mg Tocopherol Equivalent, 0.5 mg Thiamine, 0.5 mg Riboflavin, 0.5 mg Vitamin B6 , 90 μg Folic Acid,6 mg Niacin, 0.9 μg Vitamin B12, 30 mg Vitamin C, 0.56 mg Copper, 90 μg, Iodine, 17 μg Selenium, 4.1 mg Zinc, 190 Phytase-units, plus 2.5 mg Fe as FeFum and 2.5 mg Fe as NaFeEDTA, maltodextrin carrier (added up to 11g) Iron compound added to the test meal: Test meal A will contain 2.5 mg 57Fe as ferrous fumarate and 2.5 mg of iron as NaFeEDTA (given as 1.5 mg 56Fe and 1 mg 58Fe). Test meal B will contain 5 mg iron in form of FeSO₄ (3 mg 56Fe and 2 mg 54Fe).

Dietary Supplement: Fortified maize porridge (MNP+iron)

MNP+iron+GOS and test meal

ACTIVE COMPARATOR

The MNP contains 400 μg Vitamin A, 5 μgVitamin D, 5 mg Tocopherol Equivalent, 0.5 mg Thiamine, 0.5 mg Riboflavin, 0.5 mg Vitamin B6 , 90 μg Folic Acid,6 mg Niacin, 0.9 μg Vitamin B12, 30 mg Vitamin C, 0.56 mg Copper, 90 μg, Iodine, 17 μg Selenium, 4.1 mg Zinc, 190 Phytase-units, plus 2.5 mg Fe as ferrous fumarate and 2.5 mg Fe as NaFeEDTA, plus 7.5 g of galacto-oligosaccharides given as 10.5 g GOS-75, maltodextrin carrier (added up to 11g) Iron compound added to the test meal: Test meal A will contain 2.5 mg 57Fe as ferrous fumarate and 2.5 mg of iron as NaFeEDTA (given as 1.5 mg 56Fe and 1 mg 58Fe). Test meal B will contain 5 mg iron in form of FeSO₄ (3 mg 56Fe and 2 mg 54Fe).

Dietary Supplement: Fortified maize porridge (MNP+iron+GOS)

Interventions

Fortified maize porridge (MNP+iron) DIETARY_SUPPLEMENT

Maize porridge will be home-fortified with the MNP + iron. Maize porridge for the test meal will be fortified with labelled iron compounds

MNP+iron and test meal

Fortified maize porridge (MNP+iron+GOS) DIETARY_SUPPLEMENT

Maize porridge will be home-fortified with the MNP + iron + GOS. Maize porridge for the test meal will be fortified with labelled iron compounds

MNP+iron+GOS and test meal

Eligibility Criteria

• Age: 6 Months - 14 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age of 6-14 months at baseline
• Assessment of good health as assessed by professional staff at Msambweni District Hospital
• Willingness of their caregiver to provide informed consent

You may not qualify if:

• Hemoglobin \<70 g/L ; these infants will be referred for treatment according to local standard of care.
• Severe underweight (Z-score weight-for-age \<-3) and /or severe wasting (Z-score weight-for-height\<-3)
• Chronic or acute illness or other conditions that in the opinion of the Principle Investigator (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
• Participants taking part in other studies requiring the drawing of blood
• Participants who are taking iron-containing food supplements or tablets/drops
• Participants who are taking antibiotics

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead
• Jomo Kenyatta University of Agriculture and Technology: collaborator
• International Centre for Behavioural Studies: collaborator
• Msambweni District Hospital: collaborator

Study Sites (1)

Msambweni District Hopsital

Msambweni, Kwale County, Kenya

Location

Related Publications (2)

• Mikulic N, Uyoga MA, Paganini D, Mwasi E, Stoffel NU, Zeder C, Karanja S, Zimmermann MB. Consumption of a Single Dose of Prebiotic Galacto-Oligosaccharides Does Not Enhance Iron Absorption from Micronutrient Powders in Kenyan Infants: A Stable Iron Isotope Study. J Nutr. 2021 May 11;151(5):1205-1212. doi: 10.1093/jn/nxab007.

  PMID: 33693741 DERIVED

• Paganini D, Uyoga MA, Cercamondi CI, Moretti D, Mwasi E, Schwab C, Bechtler S, Mutuku FM, Galetti V, Lacroix C, Karanja S, Zimmermann MB. Consumption of galacto-oligosaccharides increases iron absorption from a micronutrient powder containing ferrous fumarate and sodium iron EDTA: a stable-isotope study in Kenyan infants. Am J Clin Nutr. 2017 Oct;106(4):1020-1031. doi: 10.3945/ajcn.116.145060. Epub 2017 Aug 16.

  PMID: 28814396 DERIVED

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Anemia; Iron Deficiencies

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Michael Zimmermann, MD

  Swiss Federal Institute of Technology (ETH), Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2016
• First Posted: January 28, 2016
• Study Start: January 1, 2016
• Primary Completion: April 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 19, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share

Locations

KE (1)