Clinical trial NCT03256123: The Effects of Biscuits Containing Red Palm Oil on School Children With Vitamin A Deficiency in West and East Malaysia
Official title: The Effect of Biscuits Containing Red Palm Oil on School Children With Vitamin A Deficiency in West and East Malaysia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vitamin A Deficiency in Children
Keywords: Vitamin A Deficiency
Iron Deficiency
Parasite
Gut Microbiota
Red palm oil
Lead sponsor: Malaysia Palm Oil Board
Sponsor class: OTHER_GOV
Collaborators: name: University of Malaya
First posted: 2017-08-21
Enrollment: 300
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this study, the subjects will be randomly assigned to two groups: a group receiving biscuits with red palm oil and a control group receiving biscuits with palm shortening with corresponding fatty acids.
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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 - 1.04 µmol/L.
* Not physically handicapped

Exclusion Criteria:

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

Primary outcomes:
measure: Retinol level
timeFrame: During screening, after 6 months of dietary intervention period and post 200 days after the intervention.
Secondary outcomes:
measure: Serum beta carotene, alpha carotene, vitamin E levels
timeFrame: During screening, after 6 months of dietary intervention period and post 200 days after the intervention.
measure: Retinol binding protein levels
timeFrame: During screening, after 6 months of dietary intervention period and post 200 days after the intervention.
measure: Hemoglobin and ferritin level
timeFrame: During screening, after 6 months of dietary intervention period and post 200 days after the intervention.
measure: Ocular signs
timeFrame: During screening, after 6 months of dietary intervention period and post 200 days after the intervention.
measure: Inflammatory/infection status
timeFrame: During screening, after 6 months of dietary intervention period and post 200 days after the intervention.
measure: Gut Microbiota
timeFrame: at the baseline, 3 months after intervention, after 6-months intervention.
measure: Soil-transmitted helminths
timeFrame: at the baseline, 3 months after intervention, after 6-months intervention.
Other outcomes:
Locations:
city: Kajang
country: Malaysia
facility: Malaysian Palm Oil Board
state: Selangor
Study officials:
affiliation: Malaysia Palm Oil Board
name: KIM TIU TENG
role: PRINCIPAL_INVESTIGATOR
affiliation: Malaysia Palm Oil Board
name: RADHIKA LOGANATHAN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Al-Mekhlafi HM, Al-Zabedi EM, Al-Maktari MT, Atroosh WM, Al-Delaimy AK, Moktar N, Sallam AA, Abdullah WA, Jani R, Surin J. Effects of vitamin A supplementation on iron status indices and iron deficiency anaemia: a randomized controlled trial. Nutrients. 2013 Dec 31;6(1):190-206. doi: 10.3390/nu6010190.
citation: 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.
citation: 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.