Proof of Concept Study to evaluate the effect of Iron and Prebiotic Supplementation in Childre

Not Applicable

Completed

• Conditions: Health Condition 1: D508- Other iron deficiency anemias

• Registration Number: CTRI/2023/03/050188
• Lead Sponsor: Dr Reddy’s Laboratories Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2024-02-02
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 44

Inclusion Criteria

Subjects must meet all the following inclusion criteria in order to participate in this study:

1. Subjects’ parents/LAR willing to sign the informed consent form and subject’s assent if child is completed 7 years of age as on the date of the informed consent

2. Subject aged greater than or equal to 3 to less than or equal to 7.0 years old children

3. Male or Female children

4. Hemoglobin (Hb) level of greater than or equal to 9 - less than or equal to 11 g/dl. If the subject has a previous hemogram report within one week of the screening date/informed consent (-7 days of informed consent), such subjects can be recruited in the study on satisfying the eligibility criteria

5. Children who had experienced at least two episodes of infection in the previous 3 months

6. Able to adjust diet or take nutrition and supplements daily

7. Able to control drinking milk, coffee, tea, or other beverages/supplements that would interfere with the Iron absorption 0.5 hour (30 minutes) before and after consuming the test supplement

8. Committed to comply with the study protocol

9. Able and willing to fill all the sections of the subject diary throughout regularly and submit it timely

Exclusion Criteria

Subject’s meeting any of the following criteria are not eligible for the study: 1. Consumed or consuming Iron or multiple micronutrient supplements 6 months prior to the screening date/informed consent date

2. History of blood transfusion

3. Consumed probiotics, prebiotics, or immune support products 30 days prior to the screening date/informed consent date

4. Known allergic reactions towards any ingredients present in the investigational product

5. Medical history of hematologic disorder or trait carrier (e.g., hemochromatosis, Beta-thalassemia)

6. History of gastrointestinal bleeding for at least 3 months

7. Any clinical evidence of severe infection, renal failure, encephalopathy, malignancy, diabetes mellitus, comorbidities including heart failure or pulmonary disease

8. Documented ongoing acute infection or inflammatory process including treatment with antibiotics within a two-week time of screening date/informed consent date

9. Presence of conditions that would affect normal response to repletion of protein and calories, such as gastrointestinal disorders including inflammatory bowel disease.

10. Hospitalization for an infectious condition within 4 weeks prior to screening date/ informed consent date

11. Any known medical, physical, or psychological condition that, in the opinion of the investigator, is incompatible with consumption of the investigational product and/or with the conduct of the study.

12. Participation in another clinical study less than 1 month before enrolment or current participation in another clinical study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Immunity <br/ ><br>2.Markers: Natural Killer cell (NK cell) activity, Immunoglobulin (IgA, IgE), Absolute Neutrophil Count (ANC), C-Reactive Protein (CRP) <br/ ><br>3.Quality of life: KIDSCREEN QOL-27 Health Questionnaire (Appendix I) for quality of life <br/ ><br>Timepoint: at baseline and 3rd month <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br>at Baseline, 1st month and 3rd month (18) <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1.Episodes of infection: Type, Number of episodes, frequency/severity, and duration of infection/allergies as reported in subject dairy by parents/LAR <br/ ><br>2.Dietary history by 24-hour dietary recall <br/ ><br>3.To evaluate ? Bowel health: Short questionnaire to be completed by parents/LAR for last three days before date <br/ ><br>4.Gut Microbiome Shift: 16S ribosomal RNA (rRNA) sequencing of fecal samples collected from randomly selected 5 subjects <br/ ><br>5.Iron Status <br/ ><br>Timepoint: at Baseline, 1st month and 3rd month <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br>at Baseline, 1st month and 3rd month <br/ ><br>baseline visit 1, first 3 days from date of visit 2 and last three days before date of Visit 3 <br/ ><br>at Baseline, 1st month and 3rd month <br/ ><br> <br/ ><br> <br/ ><br>Baseline and 3rd month <br/ ><br>