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临床试验/NCT03256123
NCT03256123已完成不适用

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

Malaysia Palm Oil Board2 个研究点 分布在 1 个国家目标入组 651 人开始时间: 2017年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
651
试验地点
2
主要终点
Retinol level

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
7 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: red palm shortening group (Dietary Supplement)

palm shortening group

Placebo Comparator

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

干预措施: palm shortening group (Dietary Supplement)

结局指标

主要结局

Retinol level

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

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.

Retinol level

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

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.

次要结局

  • 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.)
  • Soil-transmitted helminth(at the baseline, 3 months after intervention and after 6 months of dietary intervention period.)
  • Gut Microbiota(at the baseline, 3 months after intervention and after 6 months of dietary intervention period.)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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