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Vitamin A Deficiency in ChildrenNCT03256123

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

A study testing red palm shortening group and palm shortening group in people with Vitamin A Deficiency in Children, run by Malaysia Palm Oil Board at 1 site in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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%). Read more about this study

Who is it for?
Ages 7 to 11 yearsHealthy volunteers can take part
Conditions the study is for
Vitamin A Deficiency in Children
What is being tested?
red palm shortening group and palm shortening group
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
651 participants
Where
1 siteMalaysia
Study dates
1 Apr 2017to 30 Jun 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 11 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Malaysia1 site
  • Malaysian Palm Oil Board

    Kajang, Selangor, 43000

Other trials in Malaysia

About this study

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

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.

Read the 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.

Being tested
red palm shortening group, palm shortening group
Keywords
Vitamin A Deficiency, Iron Deficiency, Parasite, Gut Microbiota, Red palm oil
Medical subject headings
Vitamin A Deficiency, Iron Deficiencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • red palm shortening groupDietary supplement

    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. 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 326.3 µg RE of vitamin A/day. This would fulfill ~59.3% of the RNI of vitamin A for children aged 7-12 years old.

  • palm shortening groupDietary supplement

    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.

Study groups in NCT03256123
Study groupRoleWhat they receive
red palm shortening groupExperimentalA 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.
Receives: Dietary Supplement: red palm shortening group
palm shortening groupPlacebo comparatorA group receiving supplementation of palm shortening biscuits with corresponding fatty acids as red palm shortening group.
Receives: Dietary Supplement: palm shortening group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Retinol level

    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.

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

Secondary outcomes (7)
  1. Plasma beta carotene, alpha carotene, vitamin E levels

    Plasma beta carotene, alpha carotene, vitamin E levels are lower in Vitamin A deficiency kids

    Measured: at the baseline, after 6 months of dietary intervention period and post 200 days after the intervention.

  2. Retinol binding protein levels

    Retinol is transported in a 1-to-1 complex with retinol-binding protein. The cutoff of equimolar RBP is able to predict vitamin A deficiency

    Measured: at the baseline, after 6 months of dietary intervention period and post 200 days after the intervention.

  3. Haematological markers

    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.

    Measured: at the baseline, after 6 months of dietary intervention period and post 200 days after the intervention.

  4. 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.

    Measured: at the baseline, after 6 months of dietary intervention period and post 200 days after the intervention.

  5. Inflammatory/infection status

    high sensitivity C-reactive protein (hsCRP), haematology tests

    Measured: at the baseline, after 6 months of dietary intervention period and post 200 days after the intervention.

  6. 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.

    Measured: at the baseline, 3 months after intervention and after 6 months of dietary intervention period.

  7. Soil-transmitted helminth

    Malnutrition can weaken immune responses and increase the susceptibility to parasitic infections. Therefore, the supplementation of vitamin A to VAD children has the potential to boost their immunity against parasitic reinfections.

    Measured: at the baseline, 3 months after intervention and after 6 months of dietary intervention period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2017
  2. Study start1 Apr 2017
  3. Primary completion30 Jun 2019
  4. Study completion30 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
In this study, the subjects will be randomly assigned to two groups: a group receiving biscuits with red palm olein shortening and a control group receiving biscuits with palm olein shortening with corresponding fatty acids.
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
651 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03256123
Sponsor's protocol ID
PD219/16
Status last verified
Nov 2024
First submitted
17 Aug 2017
Last updated
10 Jul 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24384995
  • 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.

    PubMed 11271856
  • 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.

    PubMed 16846498
  • Tan PY, Lim CC, Seng KBH, Loganathan R, Lim YA, Teng KT, Mohd Johari SN, Selvaduray KR, Ramli N. Red palm olein supplementation as a potential preventive solution for xerophthalmia among vitamin A-deficient primary schoolchildren: a cluster randomized controlled trial. Eur J Clin Nutr. 2025 Sep;79(9):928-936. doi: 10.1038/s41430-025-01620-2. Epub 2025 Apr 17.

    PubMed 40247111
  • Tan PY, Loganathan R, Teng KT, Mohd Johari SN, Lee SC, Selvaduray KR, Ngui R, Lim YA. Supplementation of red palm olein-enriched biscuits improves levels of provitamin A carotenes, iron, and erythropoiesis in vitamin A-deficient primary schoolchildren: a double-blinded randomised controlled trial. Eur J Nutr. 2024 Apr;63(3):905-918. doi: 10.1007/s00394-023-03314-6. Epub 2024 Jan 19.

    PubMed 38240773

Questions about this trial

What is this clinical trial studying?

A study testing red palm shortening group and palm shortening group in people with Vitamin A Deficiency in Children, run by Malaysia Palm Oil Board at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Retinol level (time frame: During screening, after 6 months of dietary intervention period and post 200 days after the intervention.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03256123, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.

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