LETICIA Protocol Trial

Combination Food-Based and Supplemental Iron Replacement Therapy for Children with Moderate-to-Severe Anaemia in a Rural Ghanaian Setting: A Proof-of-Concept Study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

PACTR

Registry ID

PACTR201908553469676

Enrollment

100

Registered

2019-08-05

Start date

2019-10-01

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Haematological Disorders Paediatrics Iron Deficiency Anaemia

Interventions

Standard Arm

Intervention Arm

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion Criteria include the following: Children 6 – 59 months; Hb between 40 and < 70g/L at the time of screening as measured by an automated haematology analyser; Haemodynamically compensated or stable, not urgently requiring RBC transfusion; Not critically ill and needing urgent intensive care and/or surgery; and No evidence of ongoing blood loss (overtly or per facility’s standards for occult blood loss diagnosis), haemolysis (normal urobilinogen levels on urine dipstick examination), infections and temperature spikes (blood culture positive and on antibiotics)

Exclusion criteria

Exclusion criteria: Exclusion Criteria include the following: Acute phase of management for severe acute malnutrition, severe malaria and/or severe bacterial infection or sepsis requiring parenteral antibiotics; Haemodynamically unstable; heart failure, ongoing haemolysis or bleeding, on chemotherapy, aplastic anaemia; Surgery within 14 days of hospitalisation; Unable to take food or medications orally; and Recipient of chronic blood transfusion therapy

Design outcomes

Primary

Measure	Time frame
The primary outcome for the study will be the Hb concentration at day 14 of treatment with either LETICIA protocol diet combined with standard oral iron replacement therapy in the intervention group and standard oral iron replacement with typical or usual diet in the control group. Red blood cell transfusion rates in both groups will also be measured to determine the failure rates in the two groups.	—

Measure

Time frame

The primary outcome for the study will be the Hb concentration at day 14 of treatment with either LETICIA protocol diet combined with standard oral iron replacement therapy in the intervention group and standard oral iron replacement with typical or usual diet in the control group. Red blood cell transfusion rates in both groups will also be measured to determine the failure rates in the two groups.

—

Secondary

Measure	Time frame
Secondary outcome measures will include the measurements of RBC indices including MCV, MCH, RDW-CV and Ret-He and serum biochemical markers including SF, CRP, and sTfr levels for all participants We will determine the correlation between these RBC or haematological indices and the serum biochemical markers or iron status.	—

Countries

Ghana

Contacts

Public ContactLawrence Osei Tutu

KATH

oseitutlaw@gmail.com+233208611834

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026