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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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ClinicalTrials.gov Identifier: NCT03256123
Recruitment Status : Recruiting
First Posted : August 21, 2017
Last Update Posted : August 21, 2017
Sponsor:
Collaborator:
University of Malaya
Information provided by (Responsible Party):
Malaysia Palm Oil Board

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.

Condition or disease Intervention/treatment Phase
Vitamin A Deficiency in Children Dietary Supplement: red palm shortening group Dietary Supplement: palm shortening group Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: The Effect of Biscuits Containing Red Palm Oil on School Children With Vitamin A Deficiency in West and East Malaysia
Estimated Study Start Date : October 1, 2017
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin A

Arm Intervention/treatment
Experimental: red palm shortening group
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.
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.

Placebo Comparator: 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 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 Measures :
  1. Retinol level [ Time Frame: During screening, after 6 months of dietary intervention period and post 200 days after the intervention. ]
    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 :
  1. Serum beta carotene, alpha carotene, vitamin E levels [ Time Frame: During screening, after 6 months of dietary intervention period and post 200 days after the intervention. ]
    Serum beta carotene, alpha carotene, vitamin E levels are lower in Vitamin A deficiency kids

  2. Retinol binding protein levels [ Time Frame: During screening, after 6 months of dietary intervention period and post 200 days after the intervention. ]
    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

  3. Hemoglobin and ferritin level [ Time Frame: During screening, after 6 months of dietary intervention period and post 200 days after the intervention. ]
    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.

  4. Ocular signs [ Time Frame: During screening, after 6 months of dietary intervention period and post 200 days after the intervention. ]
    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.

  5. Inflammatory/infection status [ Time Frame: During screening, after 6 months of dietary intervention period and post 200 days after the intervention. ]
    high sensitivity C-reactive protein (hsCRP), fibrinogen, haematology tests

  6. Gut Microbiota [ Time Frame: at the baseline, 3 months after intervention, after 6-months intervention. ]
    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.

  7. Soil-transmitted helminths [ Time Frame: at the baseline, 3 months after intervention, after 6-months intervention. ]
    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.



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Ages Eligible for Study:   7 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03256123


Contacts
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Contact: PEI YEE TAN +6012-9363227 tpyee_april17@hotmail.com
Contact: SYAHIRAH NADIAH BINTI MOHD JOHARI +6011-32357476 syahirahnadiahmj@gmail.com

Locations
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Malaysia
Malaysian Palm Oil Board Recruiting
Kajang, Selangor, Malaysia, 43000
Contact: PEI YEE TAN    +6012-9363227    tpyee_april17@hotmail.com   
Contact: SYAHIRAH NADIAH MOHD JOHARI    +6011-32357476    syahirahnadiahmj@gmail.com   
Principal Investigator: Kim Tiu Teng         
Principal Investigator: Radhika Loganathan         
Sub-Investigator: Ai Lian Yvonne Lim         
Sub-Investigator: Soo Ching Lee         
Sub-Investigator: Romano Ngui         
Sub-Investigator: Kanga Rani Selvaduray         
Sponsors and Collaborators
Malaysia Palm Oil Board
University of Malaya
Investigators
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Principal Investigator: KIM TIU TENG Malaysia Palm Oil Board
Principal Investigator: RADHIKA LOGANATHAN Malaysia Palm Oil Board

Publications of Results:
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Responsible Party: Malaysia Palm Oil Board
ClinicalTrials.gov Identifier: NCT03256123     History of Changes
Other Study ID Numbers: PD219/16
First Posted: August 21, 2017    Key Record Dates
Last Update Posted: August 21, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Malaysia Palm Oil Board:
Vitamin A Deficiency
Iron Deficiency
Parasite
Gut Microbiota
Red palm oil

Additional relevant MeSH terms:
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Vitamin A Deficiency
Night Blindness
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vision Disorders
Eye Diseases
Vitamins
Vitamin A
Retinol palmitate
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents