Stable Iron Isotope Method in HIV+ and HIV- Children

NCT03572010 | Completed

• 1 other identifier: Fe_HIV
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to compare HIV infected children to uninfected children regarding 1) quantifying iron absorption from iron fortified maize porridge, lipid-based food supplements and oral iron supplements, and 2) quantifying the daily iron requirement.

Conditions

Iron-deficiency

Outcome Measures

Primary Outcomes (1)

• Fractional iron absorption

  Iron absorption will be measured from the 3 different types of iron vehicles from the iron deficient group (FeFum fortified maize porridge, FeSO4 containing LNS, FeSO4 supplement). It is estimated that iron absorption is lower in HIV infected children.

  Measured 14 days after consumption of the 3 different types of iron vehicles (Days 17 and 31); Enrichment shift of iron isotopes into red blood cells from Day 31 to 451

Secondary Outcomes (12)

• Hemoglobin in g/dL (in blood)

  Days -1, 17 (in iron deficient children), 31, 151, 271, 361, 451

• Plasma ferritin in µg/L (in blood)

  Days -1, 17 (in iron deficient children), 31, 151, 271, 361, 451

• Soluble transferrin receptor in mg/L (in blood)

  Days -1, 17 (in iron deficient children), 31, 151, 271, 361, 451

• Transferrin saturation in % (in blood)

  Days -1, 17 (in iron deficient children), 31, 151, 271, 361, 451

• Erythropoetin (in blood)

  Days -1, 17 (in iron deficient children), 31, 151, 271, 361, 451

Study Arms (4)

FeFum fortified maize test meal

PLACEBO COMPARATOR

Dietary Supplement: FeFum fortified maize test meal

FeSO4 fortified LNS

PLACEBO COMPARATOR

Dietary Supplement: FeSO4 fortified LNS

FeSO4 supplement

PLACEBO COMPARATOR

Dietary Supplement: FeSO4 supplement

FeSO4 fortified fruit juice

PLACEBO COMPARATOR

Dietary Supplement: FeSO4 fortified fruit juice

Interventions

FeFum fortified maize test meal DIETARY_SUPPLEMENT

Maize porridge extrinsically labeled with 2 mg ferrous fumarate (58FeFum); only for iron deficient children (defined by plasma ferritin \<40 mikrogramm/L and/or sTfR \>8.3 mg/L); cereal staple foods, like maize, depending on milling, may be high in phytic acid, a potent iron absorption inhibitor

FeFum fortified maize test meal

FeSO4 fortified LNS DIETARY_SUPPLEMENT

self-made Lipid-based nutritional supplement (LNS) extrinsically fortified and labeled with 6 mg ferrous sulfate (57FeSO4); only for iron deficient children (defined by plasma ferritin \<40 mikrogramm/L and/or sTfR \>8.3 mg/L); LNS may be a better food matrix for iron supplementation compared to maize-based porridge; contains canola oil, peanut paste, milk powder, sugar, maltodextrin and palm stearin

FeSO4 fortified LNS

FeSO4 supplement DIETARY_SUPPLEMENT

170 mg iron tablets as FeSO4 (containing 55 mg of elemental iron) with 6 mg extrinsically labeled 57Fe; will be given together with a glass of water; only for iron deficient children (defined by plasma ferritin \<40 mikrogramm/L and/or sTfR \>8.3 mg/L);

FeSO4 supplement

FeSO4 fortified fruit juice DIETARY_SUPPLEMENT

Fruit juice labeled with 12 mg 57Fe as FeSO4; in the group for iron sufficient children

FeSO4 fortified fruit juice

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 8-13 years at baseline
• Hemoglobin \>=8 g/dL
• BMI -3 to 3 SD of reference population
• HIV criteria: soluble cluster of differentiation 4 (sCD4) \>=500 cells/mm\^3, HIV RNA viral load \<50 copies/mL (measured as part of routine care)
• Plasma ferritin \<30 mikrogramm/L
• The caregiver is willing to participate in the study
• The caregiver speaks English, Afrikaans or isiXhosa
• The informed consent form has been read and signed by the caregiver (or has been read out to the caregiver in case of illiteracy) plus assent needs to be obtained from the child
• Residence in the study site for the period of the study.
• For non-iron deficient children:
• Hemoglobin \>=11.5 g/dL
• Plasma ferritin \>=40 mikrogramm/L

You may not qualify if:

• Iron supplements 3 months prior to study start
• Food allergy or intolerance against peanuts or milk
• Acute illness or 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
• Participants taking part in other studies requiring the drawing of blood
• Not planning long-term residence in study site.

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead
• University of Stellenbosch: collaborator

Study Sites (1)

Familiy Clinical Research Unit (FAMCRU)

Cape Town, South Africa

Location

Related Publications (3)

• Goosen C, Proost S, Baumgartner J, Mallick K, Tito RY, Barnabas SL, Cotton MF, Zimmermann MB, Raes J, Blaauw R. Associations of HIV and iron status with gut microbiota composition, gut inflammation and gut integrity in South African school-age children: a two-way factorial case-control study. J Hum Nutr Diet. 2023 Jun;36(3):819-832. doi: 10.1111/jhn.13171. Epub 2023 Apr 16.

  PMID: 36992541 DERIVED

• Goosen C, Proost S, Tito RY, Baumgartner J, Barnabas SL, Cotton MF, Zimmermann MB, Raes J, Blaauw R. The effect of oral iron supplementation on the gut microbiota, gut inflammation, and iron status in iron-depleted South African school-age children with virally suppressed HIV and without HIV. Eur J Nutr. 2022 Jun;61(4):2067-2078. doi: 10.1007/s00394-021-02793-9. Epub 2022 Jan 8.

  PMID: 34997267 DERIVED

• Goosen C, Baumgartner J, Mikulic N, Barnabas SL, Cotton MF, Zimmermann MB, Blaauw R. Examining Associations of HIV and Iron Status with Nutritional and Inflammatory Status, Anemia, and Dietary Intake in South African Schoolchildren. Nutrients. 2021 Mar 16;13(3):962. doi: 10.3390/nu13030962.

  PMID: 33809705 DERIVED

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: June 28, 2018
• Study Start: September 27, 2018
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: September 14, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)