Is a vitamin and mineral supplement containing a small amount of iron as useful as one with a higher amount of iron in supporting the health of Bangladeshi children living in areas with a high level of iron in drinking water sources?

Not Applicable

Completed

• Conditions: Iron deficiency anaemia; Circulatory System

• Registration Number: ISRCTN60058115
• Lead Sponsor: Griffith University

Brief Summary

2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31766250 results (added 27/11/2019) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33634319/ results (added 01/03/2021) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37602276/ Thalassemia carrier status and groundwater iron (added 02/09/2024)

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-01-31
• Study Start: 2019-07-03
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 327

Inclusion Criteria

1. Children aged 24-53 months
2. Children drinking from groundwater with a high level of iron (>=2 mg/L)
3. Guardians willing for children to participate

Exclusion Criteria

1. Children receiving antibiotic in the preceding 2 months of the enrollment.
2. Children receiving MNP or other iron supplements in the preceding 2 months of the enrollment.
3. Children with any congenital or chronic debilitating ailment.
4. Mother and the head of the household not willing to allow their child to participate in the trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Haemoglobin level in blood at baseline and endline (2 months after the start of treatment)<br>2. Serum ferritin level at baseline and endline (2 months after the start of treatment)<br>3. Soluble transferrin receptor (sTfR) level in blood at baseline and endline (2 months after the start of treatment)<br>4. Composition of gut microbiota from analysis of stool sample at baseline and endline (2 months after the start of treatment)<br>5. Incidences of morbidity, e.g. diarrhea, vomiting, respiratory infections, etc monitored weekly throughout the intervention until endline (2 months after the start of treatment)

Secondary Outcome Measures

Name	Time	Method
1. Nutritional status assessed by measuring the weight and height of the children at baseline and endline (2 months after the start of treatment)