Stable Iron Isotope Method in HIV+ and HIV- Children

NACompletedINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

September 27, 2018

Primary Completion Date

June 30, 2020

Study Completion Date

June 30, 2020

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

Trial Locations (1)

Unknown

Familiy Clinical Research Unit (FAMCRU), Cape Town

All Listed Sponsors
collaborator

University of Stellenbosch

OTHER

lead

Swiss Federal Institute of Technology

OTHER

NCT03572010 - Stable Iron Isotope Method in HIV+ and HIV- Children | Biotech Hunter | Biotech Hunter