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Efficacy of F-100, diluted F-100, and infant formula as rehabilitation diet for infants aged < 6 months with severe acute malnutrition: a randomized clinical trial

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Abstract

Purpose

To assess the efficacy and safety of F-100, diluted F-100 (F100D), and infant formula (IF) for dietary management in the rehabilitation phase of severe acute malnutrition (SAM) of infants aged under 6 months (u6m).

Methods

Double-blind randomized clinical trial was conducted to assess the efficacy and safety of F-100, F-100D, and IF at the Nutrition Rehabilitation Unit, icddr,b. Infants (n = 153) u6m with SAM were enrolled and randomly assigned to any of the three diets after stabilization. Two ml blood was collected on study days 1, 3, and 7 for measuring serum electrolytes, creatinine and osmolality, urine samples for specific gravity and osmolality creatinine ratio. Renal Solute Load (RSL) and Potential Renal Solute Load (PRSL) were calculated. Infants were discharged when gained 15% of the admission bodyweight or had edema-free weight-for-length Z-score ≥ − 2.

Results

Infants fed F-100 and F-100D had higher weight gain than infants who received IF. Mean difference between F-100 and IF was 4.6 g/kg/d (95% CI 1.5–7.6, P = 0.004) and between F-100D and IF was 3.1 g/kg/d (95% CI 0.6–5.5, P = 0.015). Total energy intake from study diet and breast milk was significantly higher in infants fed F-100 compared with other two diets (P = 0.001 in each case). RSL was highest in infants fed F-100 but serum sodium showed no sign of elevation. Urinary specific gravity and serum sodium values were within normal range.

Conclusions

F-100 can be safely used in the rehabilitation phase for infants  u6m with SAM and there is no need to prepare alternative formulations.

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Acknowledgements

The authors acknowledge the generous financial support by the Government of Bangladesh and the UKAID. The families of the infants who participated and the study staff for their relentless contribution.

Funding

This study was supported by the Government of Bangladesh and the UKAID Bangladesh.

Author information

Authors and Affiliations

  1. Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, 1212, Bangladesh

    M. Munirul Islam, Sayeeda Huq, Md Iqbal Hossain & Tahmeed Ahmed

  2. Primary Health Tasmania, Hobart, TAS, 7000, Australia

    A. M. Shamsir Ahmed

  3. Department of Population Health, London School of Hygiene and Tropical Medicine, London, UK

    Ann Ashworth

  4. Department of Paediatrics, Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders (BIRDEM), Dhaka, 1000, Bangladesh

    Md Abid Hossain Mollah

Authors
  1. M. Munirul Islam
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  2. Sayeeda Huq
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  3. Md Iqbal Hossain
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  4. A. M. Shamsir Ahmed
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  5. Ann Ashworth
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  7. Tahmeed Ahmed
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Contributions

Conceived and designed the experiments: MMI, TA, AA. Performed the experiments: MMI, SH, MIH, TA. Contributed to specific areas of methods, data analysis, statistics and write-up: all authors. Analyzed the data and wrote the first draft of the manuscript: MMI. Contributed to the writing of the manuscript and agree with the manuscript’s results and conclusions: AA, SH, MIH, AMSA, MAHM, TA. All authors have read and confirm that they meet ICMJE criteria for authorship.

Corresponding author

Correspondence to M. Munirul Islam.

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Conflict of interest

The authors declare that they have no conflict of interest.

Ethical standards

The research protocol was approved by the Institutional Review Board of icddr,b (Protocol reference no. PR10-039) which is an independent body that approves the research protocols and secures the rights of both the participants and investigators. Written informed consents were obtained from the legal guardians or parents of the participants prior to their inclusion in the study. All procedures followed in the present study were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and regional) and with the Helsinki Declaration of 1964 and all subsequent revisions [19]. It is registered with the ClinicalTrials.gov and the registration number is NCT01558440. It can be accessed at this web address: http://www.icddrb.org/research/protocols/search?keywords=PR10039&divisionId=&piName=&submit=Search& option = com_protocols&task = search&view = search&Itemid = 2205.

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Islam, M.M., Huq, S., Hossain, M.I. et al. Efficacy of F-100, diluted F-100, and infant formula as rehabilitation diet for infants aged < 6 months with severe acute malnutrition: a randomized clinical trial. Eur J Nutr 59, 2183–2193 (2020). https://doi.org/10.1007/s00394-019-02067-5

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  • DOI: https://doi.org/10.1007/s00394-019-02067-5

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