Safe and Efficacious Iron for Children in Kenya
Palabras clave
Abstracto
Descripción
Background: Fortification of local complementary foods and supplementation with micronutrient powders including iron has been shown to prevent anaemia. Iron can cause complaints (diarrhoea, constipation, etc.) related to oxidative stress in the intestine, however, and at doses conventionally used for daily supplementation, iron can increase rates of malaria and diarrhoea. A lower dose of iron (3mg/day) as NaFEEDTA can reduce these adverse effects whilst having similar or superior efficacy in improving iron status as conventional-dose iron (12.5mg) as ferrous salts.
Objective: The primary aim is to compare daily home fortification with 3mg iron as NaFeEDTA versus 12.5 mg iron as encapsulated ferrous fumarate regarding haemoglobin concentration at the end of the 30-day fortification period.
Methods: Rural children aged 12-36 months (n=324) will receive albendazole and praziquantel against helminth infections, and preventive chemotherapy against malaria with dihydroartemisinin-piperaquine. They will subsequently be randomised to daily home fortification for 30 days with sachets containing either a) 3 mg iron as NaFeEDTA; b) 12.5 mg iron as encapsulated ferrous fumarate; or c) placebo. Parents or guardians will be instructed to mix the contents of the sachets with solid or semi-solid, ready-prepared foods. Adherence will be assessed by an electronic monitoring and time-recording device in the cap of a dispensing bottle containing the sachets. At the end of the 30-day fortification period, a venous blood sample will be collected to measure indicators of iron status and inflammation. Children who received iron will continue to be followed for a maximum of 120 days after randomisation to estimate the time point when ≥10% of children has developed severe anaemia (haemoglobin concentration <70 g/L).
fechas
| Verificado por última vez: | 01/31/2014 |
| Primero enviado: | 02/24/2014 |
| Inscripción estimada enviada: | 02/24/2014 |
| Publicado por primera vez: | 02/26/2014 |
| Última actualización enviada: | 04/08/2015 |
| Última actualización publicada: | 04/09/2015 |
| Fecha de inicio real del estudio: | 05/31/2014 |
| Fecha estimada de finalización primaria: | 11/30/2014 |
| Fecha estimada de finalización del estudio: | 11/30/2014 |
Condición o enfermedad
Intervención / tratamiento
Dietary Supplement: Low-dose iron as NaFeEDTA
Dietary Supplement: Conventional dose iron as ferrous salt
Dietary Supplement: Placebo
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| Active Comparator: Low-dose iron as NaFeEDTA Daily point-of-care fortification of (complementary) foods with 3 mg iron as NaFeEDTA. | Dietary Supplement: Low-dose iron as NaFeEDTA Daily home fortification for 30 days with 3 mg iron as NaFeEDTA, vitamin A (300 RE μg as retinyl palmitate) and 5 mg zinc (as gluconate) |
| Active Comparator: Conventional dose iron as ferrous salt Daily point-of-care fortification of (complementary) foods with 12.5 mg iron as encapsulated ferrous fumarate. | Dietary Supplement: Conventional dose iron as ferrous salt Daily home fortification for 30 days with 12.5 mg iron as encapsulated ferrous fumarate, vitamin A (300 RE μg as retinyl palmitate) and 5 mg zinc (as gluconate) |
| Placebo Comparator: Placebo Daily point-of-care fortification of (complementary) foods with placebo. | Dietary Supplement: Placebo Daily home fortification for 30 days with vitamin A (300 RE μg as retinyl palmitate) and 5 mg zinc (as gluconate) |
Criterio de elegibilidad
| Edades elegibles para estudiar | 12 Months A 12 Months |
| Sexos elegibles para estudiar | All |
| Acepta voluntarios saludables | si |
| Criterios | Inclusion Criteria: 1. Aged 12-36 months; 2. Residing in the study area; 3. Planning to be in the area for the duration of the intervention and follow-up; 4. Study protocol accepted and informed consent given by at least one parent or guardian Exclusion Criteria: 1. Known or reported allergy to dihydroartemisinin, piperaquine, benzimidazole drugs or praziquantel; 2. A sibling from the same household already randomised to intervention; 3. Severely malnourished (weight-for-height z-score < -3 SD) (for ethical reasons); 4. Presence of fever (axillary temperature ≥ 37.5 ºC) (to avoid inflammation-induced effects on iron status markers); 5. Presence of reported or suspected systemic disorder (e.g. HIV infection, sickle cell disease) (to avoid inflammation-induced effects on iron status markers and to avoid attrition); 6. Missed one or several doses of the 3-day course of dihydroartemisinin-piperaquine (to ensure that participants are protected against malaria for the duration of the iron intervention); 7. No blood sample collected, or blood volume collected < 5 mL; 8. Haemoglobin concentration < 70 g/L (to prevent severe anaemia). |
Salir
Medidas de resultado primarias
1. Hemoglobin concentration [End of the 30-day fortification period]
Medidas de resultado secundarias
1. Iron status [End of the 30-day fortification period]
2. Serum concentration of non-transferrin bound iron [3 hours after ingesting the first fortificant dose]
3. Faecal calprotectin concentration [End of the 30-day fortification period]
4. P. falciparum infection [End of the 30-day fortification period]
5. Adherence to intervention [End of the 30-day fortification period]
Otras medidas de resultado
1. Haemoglobin concentration [Single measurement between 30 and 100 days after randomisation]
