The Effect of Human Milk Oligosaccharides and Galacto-oligosaccharides on Iron Absorption in Kenyan Infants

NCT04163406 | Completed

• 1 other identifier: FeHMOGOS
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

Effective and safe strategies to deliver iron to infants and young children in Sub-Saharan Africa are urgently needed. One potential strategy to improve safety of iron fortification is to limit the total amount of unabsorbed iron entering the colon by lowering the daily iron dose but at the same time ensure efficacy by maximizing absorption from this lower dose. In Kenyan infants, the investigators have recently shown that consumption of 7.5 g of the prebiotic galacto-oligosaccharides (GOS) compared to no GOS consumption increased iron absorption from an iron containing micronutrient powder by ≈60%. It is uncertain whether a lower dose of GOS can also enhance iron absorption. Another question is whether HMOs, 'natural prebiotics' found in high concentration in human breast milk, can also increase iron absorption similar to GOS. Therefore, the aim of this study is to measure fractional iron absorption from a maize-based porridge fortified with A) iron as ferrous fumarate, B) iron as ferrous fumarate and GOS and C) iron ferrous fumarate and HMOs, using an established stable iron isotope technique in 55 infants aged 8-12 months living in Msambweni and surrounding rural communities, Kwale County of southern coastal Kenya. Assessing the effect of a low dose of GOS and of HMOs on iron absorption will provide valuable information towards the development of new, highly bioavailable iron formulations for African infants. As per the local standard of care, the participants who will be iron-deficient anemic at the end of the study will be treated with oral iron supplements. To evaluate the effects of iron supplementation on iron and anemia status and to estimate obligatory iron losses in the gastrointestinal tract, blood and fecal samples will be collected before, during and fourteen days after the beginning of the treatment with oral iron supplements. Data about the efficacy of current supplementation strategies in iron-deficient anemic children and obligatory iron losses would provide additional evidence for the optimization of iron supplementation regimens.

Conditions

Anemia, Iron-deficiency

Keywords

Anemia; Iron-deficiency; Iron absorption; Prebiotic; Galacto-oligosaccharides; Human milk oligosaccharides; Infants; Kenya

Outcome Measures

Primary Outcomes (1)

• Fractional iron absorption in %

  Fractional iron absorption (%), measured as erythrocyte incorporation of stable iron isotopes at day 19

  Day 19

Secondary Outcomes (26)

• Hemoglobin (Hb)

  Baseline

• Hemoglobin (Hb)

  Day 19

• Plasma Ferritin (PF)

  Baseline

• Plasma Ferritin (PF)

  Day 19

• Soluble Transferrin Receptor (sTfR)

  Baseline

Study Arms (3)

ferrous fumarate

ACTIVE COMPARATOR

Maize-based porridge fortified with iron (5mg) as ferrous fumarate

Dietary Supplement: ferrous fumarate

ferrous fumarate + GOS

ACTIVE COMPARATOR

Maize-based porridge fortified with iron (5mg) as ferrous fumarate + GOS (3g)

Dietary Supplement: ferrous fumarate + GOS

ferrous fumarate + HMOs

ACTIVE COMPARATOR

Maize-based porridge fortified with iron (5mg) as ferrous fumarate + HMOs (2'-FL (2g) + LNnT (1g))

Dietary Supplement: ferrous fumarate + HMOs

Interventions

ferrous fumarate DIETARY_SUPPLEMENT

Maize-based porridge fortified with iron (5mg) in form of ferrous fumarate

ferrous fumarate

ferrous fumarate + GOS DIETARY_SUPPLEMENT

Maize-based porridge fortified with iron (5mg) in form of ferrous fumarate and GOS (3g)

ferrous fumarate + GOS

ferrous fumarate + HMOs DIETARY_SUPPLEMENT

Maize-based porridge fortified with iron (5mg) in form of ferrous fumarate and HMOs (2'-FL (2g) + LNnT(1g))

ferrous fumarate + HMOs

Eligibility Criteria

• Age: 8 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age of 8-12 months at baseline
• Assessment of good health as assessed by professional staff at Msambweni District Hospital
• The caregiver is willing to participate in the study
• The informed consent form has been read and signed by the caregiver (or has been read out to the caregiver in case of illiteracy)
• Residence in the study area for the period of the study
• Willingness of the caregiver to provide 2 blood samples from their child and 1 breast milk sample from the mother

You may not qualify if:

• Hb \<70 g/L
• 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
• Regular intake (\>2 days) of iron-containing mineral and vitamin supplements or fortified foods within the last 2 months

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead
• University of Zurich: collaborator
• Jomo Kenyatta University of Agriculture and Technology: collaborator
• University Children's Hospital, Zurich: collaborator

Study Sites (1)

Msambweni County Referral Hospital

Msambweni, Kwale County, Kenya

Location

Related Publications (2)

• 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 BACKGROUND

• Giorgetti A, Paganini D, Nyilima S, Kottler R, Frick M, Karanja S, Hennet T, Zimmermann MB. The effects of 2'-fucosyllactose and lacto-N-neotetraose, galacto-oligosaccharides, and maternal human milk oligosaccharide profile on iron absorption in Kenyan infants. Am J Clin Nutr. 2023 Jan;117(1):64-72. doi: 10.1016/j.ajcnut.2022.10.005. Epub 2022 Dec 15.

  PMID: 36789945 DERIVED

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Anemia

Interventions

ferrous fumarate; Health Maintenance Organizations

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Managed Care Programs; Insurance, Health; Insurance; Financing, Organized; Economics; Health Care Economics and Organizations; Prepaid Health Plans; Group Practice; Professional Practice; Organization and Administration; Health Services Administration; Delivery of Health Care; Patient Care Management

Study Officials

• Michael B Zimmermann, Prof. Dr.

  Swiss Federal Institute of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: November 14, 2019
• Study Start: November 21, 2019
• Primary Completion: November 9, 2020
• Study Completion: November 9, 2020
• Last Updated: June 23, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)