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Comparison of Oral Iron Supplement Formulations for Normalization of Iron Status Following Roux-EN-y Gastric Bypass Surgery: a Randomized Trial

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Abstract

Background

The evidence behind recommendations for treatment of iron deficiency (ID) following roux-en-y gastric bypass surgery (RYGB) lacks high quality studies.

Setting

Academic, United States

Objective

The objective of the study is to compare the effectiveness of oral iron supplementation using non-heme versus heme iron for treatment of iron deficiency in RYGB patients.

Methods

In a randomized, single-blind study, women post-RYGB and iron deficient received non-heme iron (FeSO4, 195 mg/day) or heme iron (heme-iron-polypeptide, HIP, 31.5 to 94.5 mg/day) for 8 weeks. Measures of iron status, including blood concentrations of ferritin, soluble transferrin receptor (sTfR), and hemoglobin, were assessed.

Results

At baseline, the mean ± standard deviation for age, BMI, and years since surgery of the sample was 41.5 ± 6.8 years, 34.4 ± 5.9 kg/m2, and 6.9 ± 3.1 years, respectively; and there were no differences between FeSO4 (N = 6) or HIP (N = 8) groups. Compliance was greater than 94%. The study was stopped early due to statistical and clinical differences between groups. Values before and after FeSO4 supplementation, expressed as least square means (95% CI) were hemoglobin, 10.8 (9.8, 11.9) to 13.0 (11.9, 14.0) g/dL; sTfR, 2111 (1556, 2864) to 1270 (934, 1737) μg/L; ferritin, 4.9 (3.4, 7.2) to 15.5 (10.6, 22.6) μg/L; and sTfR:ferritin ratio, 542 (273, 1086) to 103 (51, 204); all p < 0.0001. With HIP supplementation, no change was observed in any of the iron status biomarkers (all p > 0.05).

Conclusions

In accordance with recommendations, oral supplementation using FeSO4, but not HIP, was efficacious for treatment of iron deficiency after RYGB.

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Abbreviations

RYGB:

Roux-en-y gastric bypass

BMI:

Body mass index

CRP:

C-reactive protein

sTfR:

Soluble transferrin receptor

TIBC:

Total iron binding capacity

HIP:

Heme iron polypeptide

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Acknowledgements

We are grateful to the participants of the study.

Author information

Authors and Affiliations

  1. Department of Nutrition Science, Purdue University, 700 W. State Street, Stone Hall, Room 208, West Lafayette, IN, 47907, USA

    Renee A. Mischler & Nana Gletsu-Miller

  2. Department of Nutrition, University of North Carolina at Greensboro, Greensboro, NC, 27412, USA

    Seth M. Armah

  3. Department of Statistics, Purdue University, West Lafayette, IN, 47907, USA

    Bruce A. Craig

  4. Department of Biological Sciences, Purdue University, West Lafayette, IN, 47907, USA

    Arthur D. Rosen

  5. School of Medicine, Indiana University, Indianapolis, IN, 46202, USA

    Ambar Banerjee, Don J. Selzer & Jennifer N. Choi

Authors
  1. Renee A. Mischler
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Contributions

NGM and RAM designed research; AB, DJS, and JNC assisted with participant recruitment and translation of study findings; RAM and SMA conducted research; SMA and BAC analyzed data; RAM and SMA wrote the paper; ADR and JNC served as the study physicians; NGM had primary responsibility for final content. All authors have read and approved the final manuscript.

Corresponding author

Correspondence to Nana Gletsu-Miller.

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Conflict of Interest

The authors declare that they have no conflict of interest.

Funding

Colorado Biolabs Inc., Frederick, CO provided the heme supplements.

Additional information

ClinicalTrials.gov, NCT 02404012.

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Mischler, R.A., Armah, S.M., Craig, B.A. et al. Comparison of Oral Iron Supplement Formulations for Normalization of Iron Status Following Roux-EN-y Gastric Bypass Surgery: a Randomized Trial. OBES SURG 28, 369–377 (2018). https://doi.org/10.1007/s11695-017-2858-4

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