CompletedNot Applicable

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

Malaysia651 participantsStarted 2017-04-01

Plain-language 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.

Who can participate

Age range

7 Years – 11 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 - \<1.05 µmol/L. * Not physically handicapped Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Retinol level

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

Trial details

NCT IDNCT03256123

SponsorMalaysia Palm Oil Board

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2019-06-30

View on ClinicalTrials.gov More Vitamin A Deficiency in Children trials