Evaluation of the Effects of Routine Iron Supplementation in Children on Gastrointestinal Iron Losses

NCT04721964 | Completed

• 1 other identifier: FeLo
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 deficiency (ID) and IDA during childhood. In Kenya, national nutrition policies for anaemia prevention recommend a daily dose of 3-6 mg ele-mental iron per kg body weight if a child is diagnosed with anaemia. Using a novel technology, recent research found increased iron losses during iron supplementation. In an explorative analysis of stool samples collected from Gambian toddlers (Speich et al., 2020), an increase in faecal iron losses during iron supplementation was reported. The present study is aiming to analyse a relationship between routine iron supplementation and increased faecal occult blood losses in 24 Kenyan children with anaemia and iron deficiency in a more structured manner. Secondary objectives of the study are to measure and monitor iron and inflammatory status during the course of the study and to quantify long-term iron absorption and iron losses during a 12-weeks iron supplementation period, in order to put iron balance into relationship to occurring faecal occult blood losses during such an intervention.

Conditions

Iron Deficiency Anemia; Gastro Intestinal Bleeding; Iron-deficiency

Outcome Measures

Primary Outcomes (4)

• Fecal occult blood concentration

  72 h stool samples will be collected from the study participants during 4 collection periods (day 4-7 (baseline), day 32-35, day 60-63, day 95-98). Fecal occult blood concentration in the samples will be estimated from haemoglobin and porphyrin content in stool samples. These measurements will be assessed from stool aliquots, that will be shipped frozen to Mayo Clinic Laboratory (Rochester, USA), using highly specific hemoquant assay.

  Day 4-7 (baseline)

• Fecal occult blood concentration

  72 h stool samples will be collected from the study participants during 4 collection periods (day 4-7 (baseline), day 32-35, day 60-63, day 95-98). Fecal occult blood concentration in the samples will be estimated from haemoglobin and porphyrin content in stool samples. These measurements will be assessed from stool aliquots, that will be shipped frozen to Mayo Clinic Laboratory (Rochester, USA), using highly specific hemoquant assay.

  Day 32-35

• Fecal occult blood concentration

  72 h stool samples will be collected from the study participants during 4 collection periods (day 4-7 (baseline), day 32-35, day 60-63, day 95-98). Fecal occult blood concentration in the samples will be estimated from haemoglobin and porphyrin content in stool samples. These measurements will be assessed from stool aliquots, that will be shipped frozen to Mayo Clinic Laboratory (Rochester, USA), using highly specific hemoquant assay.

  Day 60-63

• Fecal occult blood concentration

  72 h stool samples will be collected from the study participants during 4 collection periods (day 4-7 (baseline), day 32-35, day 60-63, day 95-98). Fecal occult blood concentration in the samples will be estimated from haemoglobin and porphyrin content in stool samples. These measurements will be assessed from stool aliquots, that will be shipped frozen to Mayo Clinic Laboratory (Rochester, USA), using highly specific hemoquant assay.

  Day 95-98

Secondary Outcomes (40)

• Iron status: Hemoglobin (g/dl) (Hb)

  Baseline (day 7)

• Iron status: Zinc protoporphyrin (µmol/mol) (ZPP)

  Baseline (day 7)

• Iron status: Soluble Transferrin Receptor (mg/L) (sTfR)

  Baseline (day 7)

• Iron status: Serum Ferritin (ug/L) (SF)

  Baseline (day 7)

• Iron status: Serum Hepcidin (nM)

  Baseline (day 7)

Study Arms (1)

Intervention

EXPERIMENTAL

All 24 participants will daily consume 6 mg iron/kg body weight for 13 weeks to correct their anaemia and increase their iron stores.

Dietary Supplement: Ferric ammonium citrate and ferrous fumarate syrup (Ranbaxy Ranferon-12 Syrup, Ranbaxy Laboratories, Gurgaon, India)

Interventions

Ferric ammonium citrate and ferrous fumarate syrup (Ranbaxy Ranferon-12 Syrup, Ranbaxy Laboratories, Gurgaon, India) DIETARY_SUPPLEMENT

Daily supplementation with iron syrup for 13 weeks. The dosage will be calculated based on body weight and adjusted after 4 and 8 weeks of intervention

Intervention

Eligibility Criteria

• Age: 23 Months - 29 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead
• Jomo Kenyatta University of Agriculture and Technology: collaborator

Study Sites (1)

Msambweni County Referral Hospital

Mombasa, Kwale County, 8-80404, Kenya

Location

Related Publications (2)

• Speich C, Wegmuller R, Brittenham GM, Zeder C, Cercamondi CI, Buhl D, Prentice AM, Zimmermann MB, Moretti D. Measurement of long-term iron absorption and loss during iron supplementation using a stable isotope of iron (57 Fe). Br J Haematol. 2021 Jan;192(1):179-189. doi: 10.1111/bjh.17039. Epub 2020 Aug 30.

  PMID: 32862453 BACKGROUND

• Giorgetti A, Nyilima S, Stoffel NU, Moretti D, Mwasi E, Karanja S, Zeder C, Speich C, Netland C, Jin Z, Zimmermann MB, Brittenham GM. Stable iron (58Fe) isotopic measurements in Kenyan toddlers during 3 months of iron supplementation demonstrate that half of the iron absorbed is lost. Br J Haematol. 2024 May;204(5):2057-2065. doi: 10.1111/bjh.19319. Epub 2024 Feb 1.

  PMID: 38302093 DERIVED

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Gastrointestinal Hemorrhage

Interventions

ferric ammonium citrate

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nicole U Stoffel, PhD

  ETH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective intervention study

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 25, 2021
• Study Start: February 25, 2021
• Primary Completion: June 16, 2021
• Study Completion: June 16, 2021
• Last Updated: July 27, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)