Status:
COMPLETED
Evaluation of the Effects of Routine Iron Supplementation in Children on Gastrointestinal Iron Losses
Lead Sponsor:
Swiss Federal Institute of Technology
Collaborating Sponsors:
Jomo Kenyatta University of Agriculture and Technology
Conditions:
Iron Deficiency Anemia
Gastro Intestinal Bleeding
Eligibility:
All Genders
23-29 years
Phase:
NA
Brief Summary
Iron deficiency anaemia (IDA) is common among infants and young children in sub-Saharan Africa.Oral iron administration is usually recom-mended as cost effective measure to prevent and treat iron defi...
Detailed Description
Infants and young children in sub-Saharan Africa have high rates of iron deficiency anaemia (IDA), which adversely affects their growth and cognitive development. WHO recommends daily administration o...
Eligibility Criteria
Inclusion
- Participation in former Fe\_HMO\_GOS study (JKUAT/IERC No. 301019) or INSPIRE study (JKUAT/IERC No. JKU/2/4/896B).
- Mildly to moderately anaemic defined as 9.0 g/dL ≤ Hb \< 11 g/dL.
- Iron deficiency defined as ZPP \>80μmol/mol.
- Willingness of the caregiver to participate in the study.
- Residence in the study area for the period of the study.
- The informed consent form has been read and signed by the participant's caregiver (or has been read out to the participant's caregiver in case of illiteracy)
- Assessment of good health by professional staff at Msambweni District Hospital.
Exclusion
- Hb \<9 g/L or \>11 g/L.
- Zinc ProtoPorphyrin ≤80 μmol/mol.
- Severe underweight (Z-score weight-for-age ≤-3).
- Severe wasting (Z-score weight-for-height ≤-3).
- Antibiotics consumption in the 7 days prior to screening.
- Consumption of iron supplements in the 14 days prior to screening.
- Any severe metabolic, gastrointestinal, kidney or chronic disease such as diabetes, hepatitis, hypertension, cancer or cardiovascular diseases (according to the guardian's statement or medical examination (health booklet)).
- Participants taking part in other studies requiring the drawing of blood or involving medical or physical interventions.
Key Trial Info
Start Date :
February 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 16 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04721964
Start Date
February 25 2021
End Date
June 16 2021
Last Update
July 27 2021
Active Locations (1)
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1
Msambweni County Referral Hospital
Mombasa, Kwale County, Kenya, 8-80404