Comparison of home fortification with two iron formulations among Kenyan children

Rationale and design of a placebo-controlled non-inferiority trial

Emily M. Teshome*, Walter Otieno, Sofie R. Terwel, Victor Osoti, Ayşe Y. Demir, Pauline E.A. Andango, Andrew M. Prentice, Hans Verhoef

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

Introduction Home fortification powders containing iron and other micronutrients have been recommended by World Health Organisation to prevent iron deficiency anaemia in areas of high prevalence. There is evidence, however, that home fortification at this iron dose may cause gastrointestinal adverse events including diarrhoea. Providing a low dose of highly absorbable iron (3 mg iron as NaFeEDTA) may be safer because the decreased amount of iron in the gut lumen can possibly reduce the burden of these adverse effects whilst resulting in similar or higher amounts of absorbed iron. Objective To show non-inferiority of home fortification with 3 mg iron as NaFeEDTA compared with 12.5 mg iron as encapsulated ferrous fumarate, with haemoglobin response as the primary outcome. Design 338 Kenyan children aged 12–36 months will be randomly allocated to daily home fortification with either: a) 3 mg iron as NaFeEDTA (experimental treatment), b) 12.5 mg iron as encapsulated ferrous fumarate (reference), or c) placebo. At baseline, after 30 days of intervention and within 100 days post-intervention, blood samples will be assessed for primary outcome (haemoglobin concentration), iron status markers, Plasmodium parasitaemia and inflammation markers. Urine and stool samples will be assessed for hepcidin concentrations and inflammation, respectively. Adherence will be assessed by self-reporting, sachet counts and by an electronic monitoring device. Conclusion If daily home fortification with a low dose of iron (3 mg NaFeEDTA) has similar or superior efficacy to a high dose (12.5 mg ferrous fumarate) then it would be the preferred choice for treatment of iron deficiency anaemia in children.
Original languageEnglish
Pages (from-to)1-10
JournalContemporary Clinical Trials Communications
Volume7
DOIs
Publication statusPublished - 2017

Fingerprint

Iron
Placebos
Iron-Deficiency Anemias
Hemoglobins
Hepcidins
Inflammation
Plasmodium
Parasitemia
Micronutrients
Powders
Diarrhea
Urine
Equipment and Supplies
Fe(III)-EDTA
Therapeutics

Keywords

  • Adherence
  • Anaemia
  • Child
  • Dietary supplements
  • Fortification
  • Iron
  • Non-inferiority
  • Preschool

Cite this

Teshome, Emily M. ; Otieno, Walter ; Terwel, Sofie R. ; Osoti, Victor ; Demir, Ayşe Y. ; Andango, Pauline E.A. ; Prentice, Andrew M. ; Verhoef, Hans. / Comparison of home fortification with two iron formulations among Kenyan children : Rationale and design of a placebo-controlled non-inferiority trial. In: Contemporary Clinical Trials Communications. 2017 ; Vol. 7. pp. 1-10.
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abstract = "Introduction Home fortification powders containing iron and other micronutrients have been recommended by World Health Organisation to prevent iron deficiency anaemia in areas of high prevalence. There is evidence, however, that home fortification at this iron dose may cause gastrointestinal adverse events including diarrhoea. Providing a low dose of highly absorbable iron (3 mg iron as NaFeEDTA) may be safer because the decreased amount of iron in the gut lumen can possibly reduce the burden of these adverse effects whilst resulting in similar or higher amounts of absorbed iron. Objective To show non-inferiority of home fortification with 3 mg iron as NaFeEDTA compared with 12.5 mg iron as encapsulated ferrous fumarate, with haemoglobin response as the primary outcome. Design 338 Kenyan children aged 12–36 months will be randomly allocated to daily home fortification with either: a) 3 mg iron as NaFeEDTA (experimental treatment), b) 12.5 mg iron as encapsulated ferrous fumarate (reference), or c) placebo. At baseline, after 30 days of intervention and within 100 days post-intervention, blood samples will be assessed for primary outcome (haemoglobin concentration), iron status markers, Plasmodium parasitaemia and inflammation markers. Urine and stool samples will be assessed for hepcidin concentrations and inflammation, respectively. Adherence will be assessed by self-reporting, sachet counts and by an electronic monitoring device. Conclusion If daily home fortification with a low dose of iron (3 mg NaFeEDTA) has similar or superior efficacy to a high dose (12.5 mg ferrous fumarate) then it would be the preferred choice for treatment of iron deficiency anaemia in children.",
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Comparison of home fortification with two iron formulations among Kenyan children : Rationale and design of a placebo-controlled non-inferiority trial. / Teshome, Emily M.; Otieno, Walter; Terwel, Sofie R.; Osoti, Victor; Demir, Ayşe Y.; Andango, Pauline E.A.; Prentice, Andrew M.; Verhoef, Hans.

In: Contemporary Clinical Trials Communications, Vol. 7, 2017, p. 1-10.

Research output: Contribution to journalArticleAcademicpeer-review

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T2 - Rationale and design of a placebo-controlled non-inferiority trial

AU - Teshome, Emily M.

AU - Otieno, Walter

AU - Terwel, Sofie R.

AU - Osoti, Victor

AU - Demir, Ayşe Y.

AU - Andango, Pauline E.A.

AU - Prentice, Andrew M.

AU - Verhoef, Hans

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N2 - Introduction Home fortification powders containing iron and other micronutrients have been recommended by World Health Organisation to prevent iron deficiency anaemia in areas of high prevalence. There is evidence, however, that home fortification at this iron dose may cause gastrointestinal adverse events including diarrhoea. Providing a low dose of highly absorbable iron (3 mg iron as NaFeEDTA) may be safer because the decreased amount of iron in the gut lumen can possibly reduce the burden of these adverse effects whilst resulting in similar or higher amounts of absorbed iron. Objective To show non-inferiority of home fortification with 3 mg iron as NaFeEDTA compared with 12.5 mg iron as encapsulated ferrous fumarate, with haemoglobin response as the primary outcome. Design 338 Kenyan children aged 12–36 months will be randomly allocated to daily home fortification with either: a) 3 mg iron as NaFeEDTA (experimental treatment), b) 12.5 mg iron as encapsulated ferrous fumarate (reference), or c) placebo. At baseline, after 30 days of intervention and within 100 days post-intervention, blood samples will be assessed for primary outcome (haemoglobin concentration), iron status markers, Plasmodium parasitaemia and inflammation markers. Urine and stool samples will be assessed for hepcidin concentrations and inflammation, respectively. Adherence will be assessed by self-reporting, sachet counts and by an electronic monitoring device. Conclusion If daily home fortification with a low dose of iron (3 mg NaFeEDTA) has similar or superior efficacy to a high dose (12.5 mg ferrous fumarate) then it would be the preferred choice for treatment of iron deficiency anaemia in children.

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KW - Fortification

KW - Iron

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KW - Preschool

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