An interventional study of red palm shortening group and palm shortening group in Vitamin A Deficiency in Children, sponsored by Malaysia Palm Oil Board. Completed at 1 site in Malaysia. Open to participants aged 7 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-10.
Sponsored by Malaysia Palm Oil Board · Not applicable, Interventional, and Treatment
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.
Deficiency of vitamin A or retinol is a public health problem and listed as the most widespread nutritional deficiency worldwide (Sommer, 1995). According to the World Health Organization (WHO), about 190 million preschool children in underdeveloped countries especially in the region of Africa and South-East Asia are vitamin A deficient (2011, 2011). Infants and children have higher vitamin A requirements to promote rapid growth and better immunity to combat infections. Vitamin A deficiency in children causes visual impairment and blindness, risk of infection, stunting, anemia, respiratory diseases and mortality due to common childhood infections such as diarrhea and measles. On the basis on Cochrane meta-analysis on 194,795 children, vitamin A supplementation could reduce childhood mortality by 23% and incidences of illnesses (Imdad et al., 2010).
According to WHO, an estimated 2.8 million preschool-age children are at risk of nutritional blindness or active xerophthalmia due to Vitamin A deficiency in low-income countries (Organization, 2010). Sadly, approximately 250 000 to 500 000 children suffering from vitamin A deficiency become blind yearly, and half of the number die within a year of losing their vision (Organization, 2010). The different eye signs of vitamin A deficiency (VAD) in children as graded by the WHO are night blindness, conjunctival xerosis, Bitot's spots, corneal xerosis, corneal ulcer/keratomalacia and corneal scarring (Sommer, 1995). Severe vitamin A deficiency distresses ocular tissue by reducing regeneration of visual pigment upon exposure to bright light or lasting damage on the epithelium of the cornea and conjunctiva. Classical ocular manifestation due to vitamin A deficiency may lead to less serious Bitot's spots and night blindness, or severe xerophthalmia and keratomalacia leading to blindness (Scrimshaw, 2000). Ocular manifestation of vitamin A deficiency still exists in underprivileged communities in Malaysia (Ngah et al., 2002). Vitamin A deficiency is prevalent in pre-school and primary school children of aborigines ("Orang Asli") and those from rubber estates. 82.2% of Orang Asli children had ocular manifestations of vitamin A deficiency ranging from history of night blindness to corneal scars (Ngah et al., 2002). 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%) (Poh et al., 2013).
There is significant association between iron deficiency and vitamin A deficiency represented by low serum retinol (Al-Mekhlafi et al., 2013). According to WHO, iron deficiency is the commonest and widespread nutritional deficiency in the world. Over 30% of the world's population are known to be anaemic due to iron deficiency, poor diet, or exposed to infectious diseases. Malaria, HIV/AIDS, hookworm infestation, schistosomiasis, and other infections such as tuberculosis are particularly important factors contributing to the high prevalence of anaemia in some areas. Iron deficiency may lead to impaired health, development and learning in children. Based on Malaysian SEANUTS survey, the overall prevalence of iron deficiency due to low ferritin concentrations is 4.4% and anaemia based on low haemoglobin concentrations is 6.6% (Poh et al., 2013). The occurrence of anaemia and iron deficiency among Orang Asli children is relatively high. The Orang Asli children aged 2-15 years old, living in eight villages in Selangor showed high episodes of anaemia 41.5% and 36.5% had iron deficiency anaemia. In another recent study, nearly half (48.5%) of the Orang Asli children from 18 villages in Pahang were found to be anaemic and the prevalence of iron deficiency was 34% (Al-Mekhlafi et al., 2013).
In Malaysia, the school-feeding program is called "Rancangan Makanan Tambahan (RMT)" which literally means additional food plan. The RMT program is provided only to primary school children (aged 6 - 12 years) from poor families. It is not meant to replace food served at home, but to provide extra nourishment for children from poor families. The RMT program is managed by the School Division of the Ministry of Education, Malaysia. Food is served during recess time (10.30 a.m. for morning session, and 3.30pm for afternoon session) and provides 1/4 to 1/3 of daily requirements. 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.
67 studies on the registry are indexed under Vitamin A Deficiency; 7 are open to participants now.
This study's enrollment of 651 is above the median of 200 across 49 interventional studies indexed under Vitamin A Deficiency.
Browse Vitamin A Deficiency studies →Malaysia Palm Oil Board is the lead sponsor of 24 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
A group receiving supplementation of palm shortening biscuits with corresponding fatty acids as red palm shortening group.
Dietary Supplement: palm shortening group
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.
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.
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.
Time frame: During screening, after 6 months of dietary intervention period and post 200 days after the intervention.
Plasma beta carotene, alpha carotene, vitamin E levels
Plasma beta carotene, alpha carotene, vitamin E levels are lower in Vitamin A deficiency kids
Time frame: at the baseline, after 6 months of dietary intervention period and post 200 days after the intervention.
Retinol binding protein levels
Retinol is transported in a 1-to-1 complex with retinol-binding protein. The cutoff of equimolar RBP is able to predict vitamin A deficiency
Time frame: at the baseline, after 6 months of dietary intervention period and post 200 days after the intervention.
Haematological markers
vitamin A is essential for normal haematopoiesis. The occurrence of anaemia is indicated by haemoglobin concentration lower than 115 g/L. The occurrence of iron deficiency is indicated by the serum ferritin concentration lower than 15 μg/L.
Time frame: at the baseline, after 6 months of dietary intervention period and post 200 days after the intervention.
Ocular signs
Eyes examined at optimal light for conjuctival xerosis, Bitot's spots, corneal xerosis, and corneal ulceration or keratomalacia. The eye assessments include visual acuity assessment via a Snellen chart, examination with a portable slit lamp for signs of xerophthalmia, fundus photography with portable non mydriatic camera and questionnaire on night blindness symptoms.
Time frame: at the baseline, after 6 months of dietary intervention period and post 200 days after the intervention.
Inflammatory/infection status
high sensitivity C-reactive protein (hsCRP), haematology tests
Time frame: at the baseline, after 6 months of dietary intervention period and post 200 days after the intervention.
Gut Microbiota
As malnutrition is generally associated with the changes in gut microbiota \[14\], it is important to study the effects of red palm oil-fortified biscuit supplementation to gut microbiota of VAD children.
Time frame: at the baseline, 3 months after intervention and after 6 months of dietary intervention period.
Soil-transmitted helminth
Malnutrition can weaken immune responses and increase the susceptibility to parasitic infections. Therefore, the supplementation of vitamin A to VAD children has the potential to boost their immunity against parasitic reinfections.
Time frame: at the baseline, 3 months after intervention and after 6 months of dietary intervention period.
Plan to share: No
Ran from Apr 2017 to primary completion in Jun 2019, 26 months.
Of 19 interventional studies with no phase under Vitamin A Deficiency, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 26. This study's 26 months is above that.
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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Malaysia Palm Oil Board