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

Vitamin A Deficiency in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03256123
• Other study ID #: PD219/16
• Status: Recruiting
• Phase: N/A
• First received: August 17, 2017
• Last updated: August 17, 2017
• Start date: October 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2017
• Source: Malaysia Palm Oil Board
• Contact: PEI YEE TAN
• Phone: +6012-9363227
• Email: tpyee_april17[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Night Blindness
• Vitamin A Deficiency
• Vitamin A Deficiency in Children

Intervention

Dietary Supplement:
• red 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. The biscuits for each subject will contain ~200 kcal with 10 g of red palm shortening/day (630 µg RE/day). 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 630 µg RE of vitamin A/day. This would fulfill ~70% of the RNI of vitamin A for children aged 7-11 years old.
• palm shortening group
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.

Locations

Country	Name	City	State
Malaysia	Malaysian Palm Oil Board	Kajang	Selangor

Sponsors (2)

Lead Sponsor	Collaborator
Malaysia Palm Oil Board	University of Malaya

Country where clinical trial is conducted

Malaysia, 

References & Publications (3)

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. 2 — View Citation

van Stuijvenberg ME, Faber M, Dhansay MA, Lombard CJ, Vorster N, Benadé 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. — View Citation

Zeba AN, Martin Prével Y, Somé 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retinol level	Vitamin A deficiency is defined as concentration of serum retinol <0.70 µmol/L and suspected vitamin A deficiency is defined as concentration of serum retinol 0.70 - 1.04 µmol/L.	During screening, after 6 months of dietary intervention period and post 200 days after the intervention.
Secondary	Serum beta carotene, alpha carotene, vitamin E levels	Serum beta carotene, alpha carotene, vitamin E levels are lower in Vitamin A deficiency kids	During screening, after 6 months of dietary intervention period and post 200 days after the intervention.
Secondary	Retinol binding protein levels	Retinol is transported in a 1-to-1 complex with retinol-binding protein. The cutoff od equimolar RBP is able to predict vitamin A deficiency	During screening, after 6 months of dietary intervention period and post 200 days after the intervention.
Secondary	Hemoglobin and ferritin level	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.	During screening, after 6 months of dietary intervention period and post 200 days after the intervention.
Secondary	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.	During screening, after 6 months of dietary intervention period and post 200 days after the intervention.
Secondary	Inflammatory/infection status	high sensitivity C-reactive protein (hsCRP), fibrinogen, haematology tests	During screening, after 6 months of dietary intervention period and post 200 days after the intervention.
Secondary	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.	at the baseline, 3 months after intervention, after 6-months intervention.
Secondary	Soil-transmitted helminths	Malnutrition can weaken immune responses and increase the susceptibility to bacterial and parasitic infections. Therefore, the supplementation of vitamin A to VAD children has the potential to boost their immunity against bacterial and parasitic infections.	at the baseline, 3 months after intervention, after 6-months intervention.