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Safe and Efficacious Iron for Children in Kenya (SEICK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02073149
Recruitment Status : Completed
First Posted : February 27, 2014
Last Update Posted : April 10, 2015
Sponsor:
Collaborator:
Maseno University, Maseno, Kenya
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

Brief Summary:
This study will determine whether the haemoglobin response to daily home fortification for 30 days with 3mg iron as NaFeEDTA is non-inferior to 12.5 mg iron as encapsulated ferrous fumarate.

Condition or disease Intervention/treatment Phase
Anaemia Dietary Supplement: Low-dose iron as NaFeEDTA Dietary Supplement: Conventional dose iron as ferrous salt Dietary Supplement: Placebo Phase 2 Phase 3

Detailed Description:

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 338 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparison of Home Fortification With Two Iron Formulations in Kenyan Children Protected Against Malaria by Artemisinin-based Combination Therapy: a Placebo-controlled Non-inferiority Trial
Study Start Date : June 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. Hemoglobin concentration [ Time Frame: End of the 30-day fortification period ]

Secondary Outcome Measures :
  1. Iron status [ Time Frame: End of the 30-day fortification period ]
    Iron status will be assessed by plasma concentrations of ferritin and soluble transferrin receptor

  2. Serum concentration of non-transferrin bound iron [ Time Frame: 3 hours after ingesting the first fortificant dose ]
  3. Faecal calprotectin concentration [ Time Frame: End of the 30-day fortification period ]
    Faecal calprotectin concentration is used as an indicator of intestinal inflammation

  4. P. falciparum infection [ Time Frame: End of the 30-day fortification period ]
    P. falciparum infection will be defined as the presence of either asexual parasites in blood smears or parasite antigens (either histidine-rich protein-2, or Plasmodium lactate dehydrogenase) in whole blood

  5. Adherence to intervention [ Time Frame: End of the 30-day fortification period ]
    Adherence will be defined for each individual as the number of days that the dispensing bottle has been opened during the 30-day intervention period


Other Outcome Measures:
  1. Haemoglobin concentration [ Time Frame: Single measurement between 30 and 100 days after randomisation ]
    At various time points in the post-intervention period, we will sample children without replacement to measure their haemoglobin concentration. Taking into account our wish to restrict phlebotomies during the post-intervention period to a single occasion per child, we will withdraw the child from further study. These measurements should allow us to estimate the time point when ≥10% of children has developed severe anaemia (haemoglobin concentration <70 g/L).



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Ages Eligible for Study:   12 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02073149


Locations
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Kenya
Maseno University
Maseno, Nyanza Province, Kenya
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Maseno University, Maseno, Kenya
Investigators
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Principal Investigator: Hans Verhoef, PhD London School of Hygiene and Tropical Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT02073149    
Other Study ID Numbers: LSHTM-2542
First Posted: February 27, 2014    Key Record Dates
Last Update Posted: April 10, 2015
Last Verified: February 2014
Keywords provided by London School of Hygiene and Tropical Medicine:
Iron
Anemia
Sodium Fe(III)-ethylenediaminetetraacetic acid (NaFeEDTA)
Ferrous compounds
Child, preschool
Kenya
Additional relevant MeSH terms:
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Anemia
Hematologic Diseases
Iron
Fe(III)-EDTA
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action