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Stable Iron Isotope Method in HIV+ and HIV- Children

NCT03572010 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2021-09-14

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

FeFum fortified maize test meal

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

DIETARY_SUPPLEMENT

FeSO4 fortified LNS

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

DIETARY_SUPPLEMENT

FeSO4 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);

DIETARY_SUPPLEMENT

FeSO4 fortified fruit juice

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

Sponsors & Collaborators

  • University of Stellenbosch

    collaborator OTHER

  • Swiss Federal Institute of Technology

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
8 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-27
Primary Completion
2020-06-30
Completion
2020-06-30

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03572010 on ClinicalTrials.gov