Effect of Timing of Micronutrient Powder Consumption on Iron Absorption in Infants

NCT02989311 | Completed DMC

• 1 other identifier: FeGOS_Hepcidin
• Study Type: interventional
• Target: 23
• 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 by ensuring that the iron needs of infants and young children are met without changing their traditional diet. In order to optimize iron absorption timing of MNP consumption might as well be important. This is because hepcidin, a key regulator of systemic iron balance, shows a circadian increase that may influence morning versus afternoon iron absorption from the MNP. Furthermore, a single dose of iron can increase hepcidin levels and potentially inhibit iron absorption from a second dose, consumed close in time to the first dose. To determine the difference between i) morning versus afternoon iron absorption and ii) consecutive versus alternate day iron absorption, investigators will enrol 20 infants from Kwale County aged 6-14 months and conduct two studies. In study 1, infants will consume 2 test meals consisting of maize porridge containing isotopically labelled Ferrous Sulphate in the morning and afternoon on 2 days. In study 2, infants will consume 3 test meals consisting of maize porridge containing isotopically labelled Ferrous Sulphate on two consecutive days and 1 alternate day. In both studies, fourteen days after the last 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. Hepcidin concentrations will be measured before the morning and afternoon meals (study 1) and after second consecutive meal (study 2). Knowing the effect of time on the expected iron absorption will inform decisions on the ideal timing of MNP to cover the infant's requirement for absorbed iron.

Conditions

Anemia; Iron Deficiency

Keywords

Iron absorption; Iron deficiency; Hepcidin; Stable isotopes; Anemia; Infants

Outcome Measures

Primary Outcomes (1)

• Change from baseline in isotopic ratio of iron in blood at day 18 and 19 for Study 1 and 2 respectively

  Baseline and day 18, baseline and day 19

Secondary Outcomes (3)

• Hepcidin concentration

  Baseline and day 3, and day 2 for study 1 and 2 respectively

• Iron status

  Baseline and days 18 and 19 for study 1 and 2 respectively

• Inflammation status

  Baseline and days 18 and 19 for study 1 and 2 respectively

Study Arms (4)

Study 1:Morning test meal+Iron+MNP

ACTIVE COMPARATOR

The MNP contains 400 μg Vitamin A, 5 μg Vitamin 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, maltodextrin carrier (added up to 11g). Iron compound added to the morning test meal A:12 mg of iron as ferrous sulfate given as 2 mg of 57Fe and 10mg of 56Fe. Intervention: Dietary supplement: Fortified maize porridge (MNP + Iron)

Dietary Supplement: Fortified maize porridge (MNP and Iron)

Study 1:Afternoon test meal+Iron+MNP

ACTIVE COMPARATOR

The MNP contains 400 μg Vitamin A, 5 μg Vitamin 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, maltodextrin carrier (added up to 11g). Iron compound added to the afternoon test meal B:12 mg of iron as ferrous sulfate given as 2 mg of 58Fe and 10mg of 56Fe. Intervention: Dietary supplement: Fortified maize porridge (MNP + Iron)

Dietary Supplement: Fortified maize porridge (MNP and Iron)

Study 2: Consecutive meals+Iron+MNP+GOS

ACTIVE COMPARATOR

The MNP contains 400 μg Vitamin A, 5 μg Vitamin 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 meals:Test meal A will contain 12mg of ferrous sulphate given as 2mg 54Fe and 10mg 56Fe. Test meal B will contain 12mg of ferrous sulphate given as 2mg 57Fe and 10mg 56Fe. Intervention: Dietary supplement: Fortified maize porridge (MNP+ Iron + GOS)

Dietary Supplement: Fortified Maize porridge (MNP + Iron + GOS)

Study 2:Alternate meal+Iron+MNP+GOS

ACTIVE COMPARATOR

The MNP contains 400 μg Vitamin A, 5 μg Vitamin 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 C: 12mg of ferrous sulphate given as 2mg 58Fe and 10mg. Intervention: Dietary supplement: Fortified maize porridge (MNP+ Iron + GOS)

Dietary Supplement: Fortified Maize porridge (MNP + Iron + GOS)

Interventions

Fortified maize porridge (MNP and Iron) DIETARY_SUPPLEMENT

Maize porridge fortified with MNP and labelled iron compound

Study 1:Afternoon test meal+Iron+MNP; Study 1:Morning test meal+Iron+MNP

Fortified Maize porridge (MNP + Iron + GOS) DIETARY_SUPPLEMENT

Maize porridge fortified with MNP + GOS and labelled iron compound

Study 2: Consecutive meals+Iron+MNP+GOS; Study 2:Alternate meal+Iron+MNP+GOS

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 health professional staff at Msambweni County Referral 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

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead
• Jomo Kenyatta University of Agriculture and Technology: collaborator
• Msambweni County Referral Hospital: collaborator

Study Sites (1)

Msambweni County Referral Hospital

Msambweni, Kwale County, Kenya

Location

Related Publications (1)

• Uyoga MA, Mikulic N, Paganini D, Mwasi E, Stoffel NU, Zeder C, Karanja S, Zimmermann MB. The effect of iron dosing schedules on plasma hepcidin and iron absorption in Kenyan infants. Am J Clin Nutr. 2020 Oct 1;112(4):1132-1141. doi: 10.1093/ajcn/nqaa174.

  PMID: 32678434 DERIVED

MeSH Terms

Conditions

Anemia; Iron Deficiencies

Interventions

Iron

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

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: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2016
• First Posted: December 12, 2016
• Study Start: August 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 6, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will share

Locations

KE (1)