Kumbungu Trial

Not Applicable

Not yet recruiting

• Conditions: Haematological Disorders; Nutritional, Metabolic, Endocrine

• Registration Number: PACTR201906918438423
• Lead Sponsor: Ghana Michigan Collaborative research funding

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-13
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

At the cluster level, household inclusion to the study must satisfy the following:
i.Household within the selected community.
ii.The household must have at least a child aged 6 to 56 months.
Inclusion criteria at the participant level;
i.All children within the eligible household aged 6 to 56 months at baseline.
ii.Haemoglobin concentration measured at baseline should be less than 11.0 g/dl.
iii.The child should be residing in the selected community for at least the past three month.
iv.Must have a legal guardian capable of providing informed consent.

Exclusion Criteria

Eligible children with any of the following would be excluded from the study:
i.Current infective illness (example; respiratory infection, diarrhoea) with fever; however, children may be rescreened again after recovery if otherwise eligible. Current infective illness would be assessed from self-reported and verification of available medical records.
ii.Diagnosed case of any clinical haemoglobinopathy (eg, beta-thalassemia major, HbE-beta thalassemia, Sickle cell disease). This will be assessed based on self-report and available medical and laboratory records.
iii.Received iron supplements or iron-containing MMP in the previous month.

Study & Design

• Study Type: Interventional
• Study Design: Not specified