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AnaemiaPhase 2/3SEICKNCT02073149

Safe and Efficacious Iron for Children in Kenya

A Phase 2/3 study testing Low-dose iron as NaFeEDTA and Conventional dose iron as ferrous salt in people with Anaemia, run by London School of Hygiene and Tropical Medicine at 1 site in Kenya.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 36 monthsHealthy volunteers can take part
Conditions the study is for
Anaemia
What is being tested?
Low-dose iron as NaFeEDTA and Conventional dose iron as ferrous salt
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
338 participants
Where
1 siteKenya
Study dates
Jun 2014to Dec 2014
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 36 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Kenya1 site

  • Maseno University

    Maseno, Nyanza Province

Other trials in Kenya

About this study

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

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.

Read the 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).

Conditions
Anaemia
Being tested
Low-dose iron as NaFeEDTA, Conventional dose iron as ferrous salt, Placebo
Keywords
Iron, Anemia, Sodium Fe(III)-ethylenediaminetetraacetic acid (NaFeEDTA), Ferrous compounds, Child, preschool, Kenya
Medical subject headings
Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low-dose iron as NaFeEDTADietary 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)

  • Conventional dose iron as ferrous saltDietary 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)

  • PlaceboDietary supplement

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

Study groups in NCT02073149
Study groupRoleWhat they receive
Low-dose iron as NaFeEDTAActive comparatorDaily point-of-care fortification of (complementary) foods with 3 mg iron as NaFeEDTA.
Receives: Dietary Supplement: Low-dose iron as NaFeEDTA
Conventional dose iron as ferrous saltActive comparatorDaily point-of-care fortification of (complementary) foods with 12.5 mg iron as encapsulated ferrous fumarate.
Receives: Dietary Supplement: Conventional dose iron as ferrous salt
PlaceboPlacebo comparatorDaily point-of-care fortification of (complementary) foods with placebo.
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hemoglobin concentration

    Measured: End of the 30-day fortification period

Secondary outcomes (5)

  1. Iron status

    Iron status will be assessed by plasma concentrations of ferritin and soluble transferrin receptor

    Measured: End of the 30-day fortification period

  2. Serum concentration of non-transferrin bound iron

    Measured: 3 hours after ingesting the first fortificant dose

  3. Faecal calprotectin concentration

    Faecal calprotectin concentration is used as an indicator of intestinal inflammation

    Measured: End of the 30-day fortification period

  4. P. falciparum infection

    1. 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

    Measured: End of the 30-day fortification period

  5. Adherence to intervention

    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

    Measured: End of the 30-day fortification period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2014 (estimated)
  2. Study startJun 2014
  3. Primary completionDec 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
338 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02073149
Sponsor's protocol ID
LSHTM-2542
Acronym
SEICK
Status last verified
Feb 2014
First submitted
25 Feb 2014
Last updated
10 Apr 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 29391008

  • 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.

    PubMed 28770094

  • 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.

    PubMed 28449690

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Low-dose iron as NaFeEDTA and Conventional dose iron as ferrous salt in people with Anaemia, run by London School of Hygiene and Tropical Medicine at 1 site in Kenya.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hemoglobin concentration (time frame: End of the 30-day fortification period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02073149, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2015.

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