AzTrials
AzTrials

AnemiaNCT01001871

Treatment of Iron Deficiency Anemia in Malaria Endemic Ghana

A study testing Sprinkles® and vitamin/mineral fortificant without iron in people with Anemia, run by The Hospital for Sick Children at 1 site in Ghana.

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

Iron deficiency and iron deficiency anemia (IDA) are the most prevalent micronutrient deficiencies on a worldwide basis, especially in developing countries. The impact of severe IDA can have mortal consequences, since without adequate hemoglobin, the brain and body become deprived of oxygen and, if allowed to… Read more about this study

Who is it for?
Ages 6 to 24 monthsHealthy volunteers can take part
Conditions the study is for
Anemia
What is being tested?
Sprinkles® and vitamin/mineral fortificant without iron
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3,880 participants
Where
1 siteGhana
Study dates
Nov 2009to May 2011
Phase
Interventional
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 6 to 24 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Age 6-24 months
  • Ingesting weaning food in addition to breastmilk
  • Free from malaria or other major illnesses
  • Afebrile
  • Living in Brong Ahafo Region of Ghana for duration of intervention and follow-up

Who cannot join

  • Severe anemia (hemoglobin <70g/L)
  • Weight-for-height <-3 z-score(severe wasting)
  • Kwashiorkor (defined as evidence of edema)
  • Congenital abnormality
  • Treatment with iron supplements within the past 6 months
  • Presence of any chronic illness

Trial locations and contacts

1 site in 1 country.

Ghana1 site

  • Kintampo Health Research Centre

    Kintampo, PO Box 200

Other trials in Ghana

About this study

Official title: Seasonal Impact of Iron Fortification on Malaria Incidence in Ghanaian Children

Iron deficiency and iron deficiency anemia (IDA) are the most prevalent micronutrient deficiencies on a worldwide basis, especially in developing countries. The impact of severe IDA can have mortal consequences, since without adequate hemoglobin, the brain and body become deprived of oxygen and, if allowed to continue, death may ensue. It has been shown that iron supplementation in infants and young children can enhance child development, however, it may also result in increased rates of malaria in high burden areas.

The primary objective of this study is to determine the impact of providing encapsulated iron (as a powder added to complementary foods) on the susceptibility to clinical malaria among anemic and non-anemic infants and young children (6-24 months of age) living in a high malaria burden area.

The value of performing this research in Ghana is primarily that malaria and anemia remain the most important causes of death and morbidity.

Read the detailed description

Study Design:

The proposed study is a community-based blinded randomized controlled trial with 2 study arms that will be conducted in two phases:

  • Phase I will take place during the dry season (December to April), when malaria transmission rates are lower. Eligible subjects (one per household) will be individually randomized to receive a daily dose of either a powdered vitamin/mineral fortificant containing 12.5 mg of iron (plus ascorbic acid, vitamin A and zinc), or a placebo (containing all micronutrients excluding iron), added to complementary foods, for 5 months.
  • Phase II will take place during the wet season (June to October), when malaria transmission rates are higher. Eligible subjects, who did not participate in Phase I, will be individually randomized to one of the two study arms as described above and followed for 5 months.

A dual phase design, with two unique cohorts, was chosen so that preliminary results (at the end of phase 1) could be assessed by an independent Data Safety and Monitoring Committee. It is possible that during the dry season no impact of iron will be detected, while during the wet season, an impact will be observed. With this possible outcome, it is potentially feasible to translate this knowledge into a Ministry of Health Program to only provide iron supplementation (fortification) during the dry months of the year (December to April).

Conditions
Anemia
Being tested
Sprinkles®, vitamin/mineral fortificant without iron
Keywords
Iron deficiency anemia, Sprinkles®, micronutrients, malaria incidence, iron supplement
Medical subject headings
Anemia, Anemia, Iron-Deficiency

What participants receive

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

  • Sprinkles®Dietary supplement

    powdered vitamin/mineral fortificant WITH iron sprinkled onto food once a day for 5 months

  • vitamin/mineral fortificant without ironDietary supplement

    powdered vitamin/mineral fortificant WITHOUT iron sprinkled onto food once a day for 5 months

Study groups in NCT01001871
Study groupRoleWhat they receive
Vitamin/mineral fortificant with ironExperimentalNot described
Receives: Dietary Supplement: Sprinkles®
Vitamin/mineral fortificant without ironPlacebo comparatorNot described
Receives: Dietary Supplement: vitamin/mineral fortificant without iron

What is being measured

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

  1. incidence of clinical malaria (if fever recorded a blood sample will be taken to determine parasite species and count)

    Measured: 5 months

Secondary outcomes (8)

  1. changes in anemia status (blood levels of: haemoglobin(Hb) , ferritin (SF))

    Measured: 5 months

  2. severity of clinical malaria (blood parasite count)

    Measured: 5 months

  3. cerebral malaria (defined by a parasite count >5000/μL blood and a concurrent score of <2 on the Blantyre coma scale, with or without convulsions)

    Measured: 5 months

  4. hospitalization (documentation of hospitalization for any reason)

    Measured: 5 months

  5. death

    Measured: 5 months

  6. pneumonia (defined by the presence of a cough or breathing difficulties, tachypnea, lower chest wall indrawing, and the appearance of consolidation or pleural effusion on a chest X-ray)

    Measured: 5 months

  7. diarrhea (defined by >3 loose or watery stools in the previous 24 hours)

    Measured: 5 months

  8. dehydration (defined by lethargy, sunken eyes, and decreased skin turgor [>2 seconds for skin to return following a skin pinch])

    Measured: 5 months

Timeline

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

  1. First posted27 Oct 2009 (estimated)
  2. Study startNov 2009
  3. Primary completionOct 2010
  4. Study completionMay 2011

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
3,880 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01001871
Sponsor's protocol ID
1000013476
Status last verified
Apr 2021
First submitted
21 Oct 2009
Last updated
19 Apr 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • Tchum EKY, Koto JE, Kanyoke F, Opoku O, Ussher F, Dassah SD, Amoani B, Tchum SK, Nyarko E. Effect of Iron-Containing Micronutrient Powders on Growth and Malaria-Induced Anaemia Among Preschool Children in Ghana: A Cluster-Randomized, Double-Blind, Placebo-Controlled Trial. medRxiv [Preprint]. 2026 Apr 27:2026.04.24.26351649. doi: 10.64898/2026.04.24.26351649.

    PubMed 42094124

  • Tetteh Danquah A, Courtin D, Asamoah Sakyi S, Nakotey GK, Tchum SK, Afriyie Duah N, Lagrave A, Sewor C, Amoani B. HLA-G 14 bp polymorphism: Implications and its associated risk to malaria severity among iron-fortified Ghanaian infants and young children. PLoS One. 2025 Sep 15;20(9):e0322524. doi: 10.1371/journal.pone.0322524. eCollection 2025.

    PubMed 40953010

  • Tchum SK, Sakyi SA, Arthur F, Adu B, Abubakar LA, Oppong FB, Dzabeng F, Amoani B, Gyan T, Asante KP. Effect of iron fortification on anaemia and risk of malaria among Ghanaian pre-school children with haemoglobinopathies and different ABO blood groups. BMC Nutr. 2023 Mar 23;9(1):56. doi: 10.1186/s40795-023-00709-w.

    PubMed 36959634

  • Tchum SK, Sakyi SA, Adu B, Arthur F, Oppong FB, Dzabeng F, Amoani B, Gyan T, Poku-Asante K. Impact of IgG response to malaria-specific antigens and immunity against malaria in pre-school children in Ghana. A cluster randomized, placebo-controlled trial. PLoS One. 2021 Jul 20;16(7):e0253544. doi: 10.1371/journal.pone.0253544. eCollection 2021.

    PubMed 34283841

  • Aimone AM, Brown P, Owusu-Agyei S, Zlotkin SH, Cole DC. Impact of iron fortification on the geospatial patterns of malaria and non-malaria infection risk among young children: a secondary spatial analysis of clinical trial data from Ghana. BMJ Open. 2017 Jun 6;7(5):e013192. doi: 10.1136/bmjopen-2016-013192.

    PubMed 28592572

  • Aimone AM, Brown PE, Zlotkin SH, Cole DC, Owusu-Agyei S. Geo-spatial factors associated with infection risk among young children in rural Ghana: a secondary spatial analysis. Malar J. 2016 Jul 8;15:349. doi: 10.1186/s12936-016-1388-1.

    PubMed 27391972

  • Zlotkin S, Newton S, Aimone AM, Azindow I, Amenga-Etego S, Tchum K, Mahama E, Thorpe KE, Owusu-Agyei S. Effect of iron fortification on malaria incidence in infants and young children in Ghana: a randomized trial. JAMA. 2013 Sep 4;310(9):938-47. doi: 10.1001/jama.2013.277129.

    PubMed 24002280

Questions about this trial

What is this clinical trial studying?

A study testing Sprinkles® and vitamin/mineral fortificant without iron in people with Anemia, run by The Hospital for Sick Children at 1 site in Ghana.

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 5 inclusion and 6 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 19 Apr 2021. 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 Ghana. 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.

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?

incidence of clinical malaria (if fever recorded a blood sample will be taken to determine parasite species and count) (time frame: 5 months). 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 NCT01001871, which also lists 7 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 19 Apr 2021.

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