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

Primary Purpose

Vitamin A Deficiency in Children

Status
Unknown status
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
red palm shortening group
palm shortening group
Sponsored by
Malaysia Palm Oil Board
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitamin A Deficiency in Children focused on measuring Vitamin A Deficiency, Iron Deficiency, Parasite, Gut Microbiota, Red palm oil

Eligibility Criteria

7 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Malaysian Palm Oil BoardRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

red palm shortening group

palm shortening group

Arm Description

A group receiving the supplementation of red palm shortening biscuits. The subjects are expected to receive 630 µg RE of vitamin A/day by consuming the biscuits four days a week.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Serum beta carotene, alpha carotene, vitamin E levels
Serum beta carotene, alpha carotene, vitamin E levels are lower in Vitamin A deficiency kids
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
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.
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.
Inflammatory/infection status
high sensitivity C-reactive protein (hsCRP), fibrinogen, haematology tests
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.
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.

Full Information

First Posted
August 17, 2017
Last Updated
August 17, 2017
Sponsor
Malaysia Palm Oil Board
Collaborators
University of Malaya
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1. Study Identification

Unique Protocol Identification Number
NCT03256123
Brief Title
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

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2017 (Anticipated)
Primary Completion Date
June 30, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Malaysia Palm Oil Board
Collaborators
University of Malaya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin A Deficiency in Children
Keywords
Vitamin A Deficiency, Iron Deficiency, Parasite, Gut Microbiota, Red palm oil

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
red palm shortening group
Arm Type
Experimental
Arm Description
A group receiving the supplementation of red palm shortening biscuits. The subjects are expected to receive 630 µg RE of vitamin A/day by consuming the biscuits four days a week.
Arm Title
palm shortening group
Arm Type
Placebo Comparator
Arm Description
A group receiving supplementation of palm shortening biscuits with corresponding fatty acids as red palm shortening group.
Intervention Type
Dietary Supplement
Intervention Name(s)
red palm shortening group
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
palm shortening group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Retinol level
Description
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.
Time Frame
During screening, after 6 months of dietary intervention period and post 200 days after the intervention.
Secondary Outcome Measure Information:
Title
Serum beta carotene, alpha carotene, vitamin E levels
Description
Serum beta carotene, alpha carotene, vitamin E levels are lower in Vitamin A deficiency kids
Time Frame
During screening, after 6 months of dietary intervention period and post 200 days after the intervention.
Title
Retinol binding protein levels
Description
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
Time Frame
During screening, after 6 months of dietary intervention period and post 200 days after the intervention.
Title
Hemoglobin and ferritin level
Description
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
During screening, after 6 months of dietary intervention period and post 200 days after the intervention.
Title
Ocular signs
Description
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
During screening, after 6 months of dietary intervention period and post 200 days after the intervention.
Title
Inflammatory/infection status
Description
high sensitivity C-reactive protein (hsCRP), fibrinogen, haematology tests
Time Frame
During screening, after 6 months of dietary intervention period and post 200 days after the intervention.
Title
Gut Microbiota
Description
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, after 6-months intervention.
Title
Soil-transmitted helminths
Description
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.
Time Frame
at the baseline, 3 months after intervention, after 6-months intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
PEI YEE TAN
Phone
+6012-9363227
Email
tpyee_april17@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
SYAHIRAH NADIAH BINTI MOHD JOHARI
Phone
+6011-32357476
Email
syahirahnadiahmj@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
KIM TIU TENG
Organizational Affiliation
Malaysia Palm Oil Board
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
RADHIKA LOGANATHAN
Organizational Affiliation
Malaysia Palm Oil Board
Official's Role
Principal Investigator
Facility Information:
Facility Name
Malaysian Palm Oil Board
City
Kajang
State/Province
Selangor
ZIP/Postal Code
43000
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PEI YEE TAN
Phone
+6012-9363227
Email
tpyee_april17@hotmail.com
First Name & Middle Initial & Last Name & Degree
SYAHIRAH NADIAH MOHD JOHARI
Phone
+6011-32357476
Email
syahirahnadiahmj@gmail.com
First Name & Middle Initial & Last Name & Degree
Kim Tiu Teng
First Name & Middle Initial & Last Name & Degree
Radhika Loganathan
First Name & Middle Initial & Last Name & Degree
Ai Lian Yvonne Lim
First Name & Middle Initial & Last Name & Degree
Soo Ching Lee
First Name & Middle Initial & Last Name & Degree
Romano Ngui
First Name & Middle Initial & Last Name & Degree
Kanga Rani Selvaduray

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24384995
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.
Results Reference
result
PubMed Identifier
11271856
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.
Results Reference
result
PubMed Identifier
16846498
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.
Results Reference
result

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

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