The Effects of Biscuits Containing Red Palm Oil on School Children With Vitamin A Deficiency in West and East Malaysia

NCT03256123 | Completed

• 1 other identifier: PD219/16
• Study Type: interventional
• Target: 651
• Locations: 1 country
• Sites: 1

Brief Summary

Based on recent nutrition survey (SEANUTS Malaysia) on a total of 3542 Malaysian Children aged between 6 months to 12 years old, 4.4% of the children had vitamin A deficiency. Rural areas recorded a higher prevalence of vitamin A deficiency (6.4%) compared with urban areas (3.8%). Besides, prevalence of iron deficiency due to low ferritin concentrations is 4.4% and anaemia based on low haemoglobin concentrations is 6.6%. It is proposed that a red palm oil intervention programme to be conducted in alliance with RMT in Malaysia to enhance the Vitamin A status of school children in underprivileged community in Malaysia.

Conditions

Vitamin A Deficiency in Children

Keywords

Vitamin A Deficiency; Iron Deficiency; Parasite; Gut Microbiota; Red palm oil

Outcome Measures

Primary Outcomes (1)

• Retinol level

  Vitamin A deficiency is defined as concentration of blood retinol \<0.70 µmol/L and suspected vitamin A deficiency is defined as concentration of blood retinol 0.70 - \<1.05 µmol/L.

  During screening, after 6 months of dietary intervention period and post 200 days after the intervention.

Secondary Outcomes (7)

• Plasma beta carotene, alpha carotene, vitamin E levels

  at the baseline, after 6 months of dietary intervention period and post 200 days after the intervention.

• Retinol binding protein levels

  at the baseline, after 6 months of dietary intervention period and post 200 days after the intervention.

• Haematological markers

  at the baseline, after 6 months of dietary intervention period and post 200 days after the intervention.

• Ocular signs

  at the baseline, after 6 months of dietary intervention period and post 200 days after the intervention.

• Inflammatory/infection status

  at the baseline, after 6 months of dietary intervention period and post 200 days after the intervention.

Study Arms (2)

red palm shortening group

EXPERIMENTAL

A group receiving the supplementation of red palm shortening biscuits. The subjects are expected to receive 326.3 µg RE of vitamin A/day by consuming the biscuits four days a week.

Dietary Supplement: red palm shortening group

palm shortening group

PLACEBO COMPARATOR

A group receiving supplementation of palm shortening biscuits with corresponding fatty acids as red palm shortening group.

Dietary Supplement: palm shortening group

Interventions

red palm shortening group DIETARY_SUPPLEMENT

Biscuits made of red palm shortening will be distributed to the subjects given four days a week on schooling days for a duration of 6 months. This biscuit would be given four days a week on schooling days for a duration of 6 months. On average in a week, subject is expected to receive 326.3 µg RE of vitamin A/day. This would fulfill \~59.3% of the RNI of vitamin A for children aged 7-12 years old.

red palm shortening group

palm shortening group DIETARY_SUPPLEMENT

Biscuits made of palm shortening (control group) will be distributed to the subjects given four days a week on schooling days for a duration of 6 months. The palm shortening biscuits contain corresponding fatty acids as red palm shortening group.

palm shortening group

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 7-11 years old
• Vitamin A deficient children defined as concentration of serum retinol \<0.70 µmol/L and suspected vitamin A deficiency defined as concentration of serum retinol 0.70 - \<1.05 µmol/L.
• Not physically handicapped

You may not qualify if:

• Children with oedema including severe acute malnutrition or gastrointestinal disorders
• Children allergic to wheat- and/or gluten-containing foods
• Children who are studying Primary Six

Sponsors & Collaborators

• Malaysia Palm Oil Board: lead
• University of Malaya: collaborator

Study Sites (1)

Malaysian Palm Oil Board

Kajang, Selangor, 43000, Malaysia

Location

Related Publications (5)

• Gemmell HG, Smith FW, Innes A, Edward N, Catto GR. The value of Tc-DTPA transit times and NMR T1 measurements in monitoring the progress of renal transplants. Nucl Med Commun. 1985 Feb;6(2):67-74.

  PMID: 3916855 BACKGROUND

• van Stuijvenberg ME, Faber M, Dhansay MA, Lombard CJ, Vorster N, Benade AJ. Red palm oil as a source of beta-carotene in a school biscuit used to address vitamin A deficiency in primary school children. Int J Food Sci Nutr. 2000;51 Suppl:S43-50. doi: 10.1080/096374800750049567.

  PMID: 11271856 BACKGROUND

• Zeba AN, Martin Prevel Y, Some IT, Delisle HF. The positive impact of red palm oil in school meals on vitamin A status: study in Burkina Faso. Nutr J. 2006 Jul 17;5:17. doi: 10.1186/1475-2891-5-17.

  PMID: 16846498 BACKGROUND

• Tan PY, Lim CC, Seng KBH, Loganathan R, Lim YA, Teng KT, Mohd Johari SN, Selvaduray KR, Ramli N. 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. 2025 Sep;79(9):928-936. doi: 10.1038/s41430-025-01620-2. Epub 2025 Apr 17.

  PMID: 40247111 DERIVED

• Tan PY, Loganathan R, Teng KT, Mohd Johari SN, Lee SC, Selvaduray KR, Ngui R, Lim YA. Supplementation of red palm olein-enriched biscuits improves levels of provitamin A carotenes, iron, and erythropoiesis in vitamin A-deficient primary schoolchildren: a double-blinded randomised controlled trial. Eur J Nutr. 2024 Apr;63(3):905-918. doi: 10.1007/s00394-023-03314-6. Epub 2024 Jan 19.

  PMID: 38240773 DERIVED

MeSH Terms

Conditions

Vitamin A Deficiency; Iron Deficiencies

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Iron Metabolism Disorders; Metabolic Diseases

Study Officials

• KIM TIU TENG

  Malaysia Palm Oil Board

  PRINCIPAL INVESTIGATOR

• RADHIKA LOGANATHAN

  Malaysia Palm Oil Board

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: In this study, the subjects will be randomly assigned to two groups: a group receiving biscuits with red palm olein shortening and a control group receiving biscuits with palm olein shortening with corresponding fatty acids.

Study Record Dates

• First Submitted: August 17, 2017
• First Posted: August 21, 2017
• Study Start: April 1, 2017
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: July 10, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)