Safe and Efficacious Iron for Children in Kenya

NCT02073149 | Completed Phase 2

• 1 other identifier: LSHTM-2542
• Study Type: interventional
• Target: 338
• Locations: 1 country
• Sites: 1

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.

Conditions

Anaemia

Keywords

Iron; Anemia; Sodium Fe(III)-ethylenediaminetetraacetic acid (NaFeEDTA); Ferrous compounds; Child, preschool; Kenya

Outcome Measures

Primary Outcomes (1)

• Hemoglobin concentration

  End of the 30-day fortification period

Secondary Outcomes (5)

• Iron status

  End of the 30-day fortification period

• Serum concentration of non-transferrin bound iron

  3 hours after ingesting the first fortificant dose

• Faecal calprotectin concentration

  End of the 30-day fortification period

• P. falciparum infection

  End of the 30-day fortification period

• Adherence to intervention

  End of the 30-day fortification period

Other Outcomes (1)

• Haemoglobin concentration

  Single measurement between 30 and 100 days after randomisation

Study Arms (3)

Low-dose iron as NaFeEDTA

ACTIVE COMPARATOR

Daily point-of-care fortification of (complementary) foods with 3 mg iron as NaFeEDTA.

Dietary Supplement: Low-dose iron as NaFeEDTA

Conventional dose iron as ferrous salt

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

Daily point-of-care fortification of (complementary) foods with placebo.

Dietary Supplement: Placebo

Interventions

Low-dose iron as NaFeEDTA DIETARY_SUPPLEMENT

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)

Low-dose iron as NaFeEDTA

Conventional dose iron as ferrous salt DIETARY_SUPPLEMENT

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)

Conventional dose iron as ferrous salt

Placebo DIETARY_SUPPLEMENT

Daily home fortification for 30 days with vitamin A (300 RE μg as retinyl palmitate) and 5 mg zinc (as gluconate)

Placebo

Eligibility Criteria

• Age: 12 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Aged 12-36 months;
• Residing in the study area;
• Planning to be in the area for the duration of the intervention and follow-up;
• Study protocol accepted and informed consent given by at least one parent or guardian

You may not qualify if:

• Known or reported allergy to dihydroartemisinin, piperaquine, benzimidazole drugs or praziquantel;
• A sibling from the same household already randomised to intervention;
• Severely malnourished (weight-for-height z-score \< -3 SD) (for ethical reasons);
• Presence of fever (axillary temperature ≥ 37.5 ºC) (to avoid inflammation-induced effects on iron status markers);
• 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);
• 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);
• No blood sample collected, or blood volume collected \< 5 mL;
• Haemoglobin concentration \< 70 g/L (to prevent severe anaemia).

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• Maseno University: collaborator

Study Sites (1)

Maseno University

Maseno, Nyanza Province, Kenya

Location

Related Publications (3)

• Teshome EM, Oriaro VS, Andango PEA, Prentice AM, Verhoef H. Adherence to home fortification with micronutrient powders in Kenyan pre-school children: self-reporting and sachet counts compared to an electronic monitoring device. BMC Public Health. 2018 Feb 1;18(1):205. doi: 10.1186/s12889-018-5097-2.

  PMID: 29391008 DERIVED

• Teshome EM, Prentice AM, Demir AY, Andang'o PEA, Verhoef H. Diagnostic utility of zinc protoporphyrin to detect iron deficiency in Kenyan preschool children: a community-based survey. BMC Hematol. 2017 Jul 27;17:11. doi: 10.1186/s12878-017-0082-z. eCollection 2017.

  PMID: 28770094 DERIVED

• Teshome EM, Andang'o PEA, Osoti V, Terwel SR, Otieno W, Demir AY, Prentice AM, Verhoef H. Daily home fortification with iron as ferrous fumarate versus NaFeEDTA: a randomised, placebo-controlled, non-inferiority trial in Kenyan children. BMC Med. 2017 Apr 28;15(1):89. doi: 10.1186/s12916-017-0839-z.

  PMID: 28449690 DERIVED

MeSH Terms

Conditions

Anemia

Interventions

Iron; Fe(III)-EDTA

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Hans Verhoef, PhD

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2014
• First Posted: February 27, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 10, 2015

Record last verified: 2014-02

Locations

KE (1)