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Red palm olein supplementation as a potential preventive solution for xerophthalmia among vitamin A-deficient primary schoolchildren: a cluster randomized controlled trial

Abstract

Objective

This study aimed to investigate the effectiveness of carotenoid-rich red palm olein (RPO) in treating or preventing xerophthalmia among Malaysian rural primary schoolchildren with confirmed vitamin A deficiency (VAD) (plasma retinol <0.70 µmol/L) and marginal vitamin A status (plasma retinol 0.70 to <1.05 µmol/L).

Methods

A double-blinded, cluster randomized controlled trial was conducted on 504 schoolchildren aged 8–12 years from ten rural primary schools in Malaysia. The selected schools were randomly assigned into two groups: the experimental group (n = 249) received RPO-enriched biscuits (326.3 µg retinol equivalents/day), while the control group (n = 255) received palm olein (PO)-enriched biscuits for 6 months (4 days/week). Chi-square test and mixed effects logistic regression model were applied to examine the effects of supplementation on the resolution or prevention of xerophthalmia.

Results

After 6-month supplementation, a higher resolution rate of xerophthalmia (31.2%) was observed in the experimental group compared to the control group (24.1%), but this difference lacked statistical significance (p = 0.11). Nevertheless, the experimental group showed a significantly higher prevention rate of xerophthalmia (81.8%) or conjunctival xerosis (82.5%) than the control group (56.5% or 57.6%, respectively) after 6-month supplementation (p < 0.001). Moreover, schoolchildren in the experimental group were 4.8 times less likely to develop xerophthalmia compared to the control group.

Conclusion

A 6-month supplementation of RPO-enriched biscuits demonstrated potential benefits in preventing xerophthalmia or conjunctival xerosis among vitamin A-deficient primary schoolchildren in rural areas of Malaysia. Therefore, RPO may offer a promising preventive solution to xerophthalmia for populations at a high risk of developing VAD.

Clinical trial registration

ClinicalTrials.gov (NCT03256123).

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Data availability

The datasets generated and/or analyzed during the current study are not publicly available due to their containing information that could compromise the privacy of research participants but are available from the corresponding authors, RL and NR on reasonable request.

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Acknowledgements

We acknowledge with gratitude the MOE Malaysia, MOH Malaysia, and JAKOA, the head of Orang Asli villages (Tok Batin), school principals, and teachers for the permissions to perform sample and data collections from the schoolchildren. Our deepest appreciation extends to Carotino Sdn. Bhd., Noraini’s Cookies Worldwide Sdn. Bhd., Pott Glasses Sdn. Bhd., Focus Point Sdn. Bhd., doctors, medical assistants, nurses, MPOB research assistants, and internship students for their valuable support and assistance throughout the study. Of utmost importance, we thank all the schoolchildren and their parents for their voluntary participation in this study.

Funding

This work was supported by a public funding, RMK-11 (Eleventh Malaysia Plan) Grant [PD219/16], managed by the Malaysian Palm Oil Board.

Author information

Authors and Affiliations

Authors

Contributions

RL, YALL, KTT, KRS and NR were involved in the conceptualization and design of the study. PYT, CCL, KBHS and SNMJ performed the project administration including sample, data collection, handling of resources and analysis of the samples. PYT and CCL performed the data analysis and interpretation of results. PYT conducted the manuscript writing and editing. RL, YALL, KTT, KRS and NR reviewed and edited the manuscript. All authors read and approved the final version of the manuscript.

Corresponding authors

Correspondence to Radhika Loganathan or Norlina Ramli.

Ethics declarations

Competing interests

PYT, RL and KRS are employees of the Malaysian Palm Oil Board, who received and managed funding from the RMK-11 (Eleventh Malaysia Plan) Grant-PD219/16 (public funding), and conducted the study. KTT was formerly employed by the Malaysian Palm Oil Board when the study was conducted. The funder was not involved in the study design, collection, analysis and interpretation of data, the writing of the article, or the decision to submit it for publication. Other authors declare no conflicts of interest.

Ethical approval

The study adhered to the principles outlined in the Declaration of Helsinki and was registered at ClinicalTrials.gov under the identifier NCT03256123. Ethical approval was received from the Medical Research Ethics Committee, Ministry of Health (MOH) Malaysia (NMRR No: NMRR-16-1905-32547). The study was also approved with the participation of the respective health and education authorities. Before the study began, all literate parents provided written informed consents, while illiterate parents gave verbal consents and marked their thumbprints on the consent form, which were witnessed and formally documented. The parents were fully informed about the voluntary nature of their child’s participation, and their right to withdraw at any time. No child was withheld from receiving necessary medical care as part of the study protocol. Furthermore, the participants themselves signed an assent form.

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Tan, P.Y., Lim, C.C., Seng, K.B.H. et al. Red palm olein supplementation as a potential preventive solution for xerophthalmia among vitamin A-deficient primary schoolchildren: a cluster randomized controlled trial. Eur J Clin Nutr 79, 928–936 (2025). https://doi.org/10.1038/s41430-025-01620-2

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