Vitamin A StatusEVALNCT03056625
Efficacy of Vitamin A Fortified Rice in Lactating Thai Women
A study testing Vitamin A fortified rice and Normal rice in people with Vitamin A Status, run by Prince of Songkla University at 1 site in Thailand.
Trial summary
Vitamin A deficiency (VAD) remains a public health problem that occurs in children and women. WHO estimates that 190 million preschool age children (under five years of age) and 19.1 million pregnant women have inadequate concentrations of retinol . Read more about this study
- Who is it for?
- Ages 18 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin A Status
- What is being tested?
- Vitamin A fortified rice and Normal rice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteThailand
- Study dates
- 15 Mar 2017to 24 Dec 2017
- 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 18 to 38 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- free of diseases
- gestational age between 37 to 42 weeks
- willing to breastfeed for a period of 4-6 months
Who cannot join
- Hb > 70 g/L
- Postpartum Hemorrhage
- Twin, Baby with low birth weight
- Receiving vitamin A supplement during the study
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Prince of Songkla University
Pattani, 94000
Siwaporn Pinkaew, Ph.D, 899772266, siwaporn.p@psu.ac.th
About this study
Vitamin A deficiency (VAD) remains a public health problem that occurs in children and women. WHO estimates that 190 million preschool age children (under five years of age) and 19.1 million pregnant women have inadequate concentrations of retinol . VAD may increase risk of morbidity and mortality during childhood, pregnancy and postpartum period . In developing countries, vitamin A status in lactating women is not optimal. Even in the United States, vitamin A status of low income pregnant women is marginal. Therefore, women of reproductive age are at risk of vitamin A depletion which compromises the vitamin A status of breastfed infants. Vitamin A is transferred to milk from both retinol binding protein bound and chylomicron associated vitamin A carriers. Because of teratogenicity of vitamin A, the transfer of vitamin A from pregnant mother to the fetus is carefully controlled. This results in all infants born with very low stores of vitamin A . Therefore human milk is still the best vitamin A source for infants. The concentration of vitamin A in breast milk is highest in the first 21 days postpartum (colostrum in the first 4-6 days and transitional milk in the next 7-21 days). Breast milk vitamin A concentrations and an infant's vitamin A status are based on maternal dietary intake. Breast milk retinol concentrations are a useful tool and a unique indicator for lactating women and represents extrapolations of vitamin A status of breastfed infant.
In high risk vitamin A deficiency areas, prior recommendation for lactating women was to give two doses of 200,000 IU vitamin A within 6 weeks post-delivery . However, the lack of impact evidence of this regimen led to the WHO's withdrawal of such recommendation as a public health policy .
Read more
Food-based intervention has been regarded as a sustainable approach to improve population vitamin A status. Most recently, vitamin A-depleted sows fed high-provitamin A carotenoid maize resulted in significant increase in liver stores in nursing piglets and significant higher milk retinol concentrations than sows fed white maize that given a high-dose vitamin A supplement .
Previous efforts to fortify staples or common vehicles with vitamin A offer promising solution to prevention of vitamin A deficiency in vulnerable population . Food fortified with vitamin A has potentials to improve women's vitamin A status and to increase the vitamin A concentrations of breast milk . Rice as the most important staple food in Thailand, represents the culture of consumption and lifestyle of Thai people . Recent study in Thai school children fed with extruded rice grains fortified with zinc, iron and vitamin A every weekday for 2 months, significantly increased liver stores of vitamin A, as assessed with a stable isotope technique . Likewise, fortification of rice with vitamin A may also benefit mothers during lactation.
The outcomes of this study will be useful to guide the promotion of food-based strategies to improve vitamin A status of mother and infant during lactation.
Read the detailed description
Objectives To determine the efficacy of vitamin A fortified rice that gets into the breast milk of lactating mothers as determined by breast milk vitamin A concentrations, total body reserves of vitamin A via isotope dilution technique, following a 14 weeks feeding trial of lactating women.
Methodology The intervention will have two arms, vitamin A fortified rice and regular rice with 35 participants (lactating women) per group. Participants will receive one meal per day on weekdays for a period of 14 weeks. The fortified dose will be measured in the final cooked product, but we will aim to administer approximately 500 µg retinol in the rice meal. Vitamin A fortified rice is produced by extrusion technology by adding retinol into an artificial rice to be mix with the normal rice.
Data collection
- Demographic data Each participants will be asked about demographic data in the first interview. The data includes general information (age, education and occupation), socioeconomic status, number of child and duration of breastfeeding mothers, if women had a child before.
- Anthropometric data Anthropometric measurements include weight and height of participants and weight, length and head circumference of infants will be recorded in the first day and post-intervention.
- Dietary assessment At the baseline (Day 1: 3+1 week after first breastfeed), all participants will be interviewed on food consumption in the previous 24 hours for 3 times (2 weekdays and 1 weekend day). The data consist of food items, food types, food components and weight or size of consumed portions. Information from the interviews will be analyzed by INMUCAL software (Mahidol University, Thailand)
- Collection and analysis of breast milk sample Breast milk samples will be collected for vitamin A analysis. Collection of breast milk sample will be divided into two periods at the following time points which will start 3+1 week after first breastfeed.
- at baseline: Day 1 and 15
- 14 weeks post-intervention: Day 121 and 135
- Collection and analysis of blood sample The change of vitamin A status of participants will be determined by using the pair13C-retinol isotope dilution test . This involves giving the first dose of 2 µmol retinol equivalent of 13C2-retinolretinyl acetate to participants on day 1 after that the second dose (2 µmol retinol) will be given to participants on the day 121. Blood sample will be collected 4 times (Day 1, 15, 121 and 135 after 3+1 week of first breastfeed) for measuring the isotopic ratio of 13C/12C and the calculation of liver vitamin A concentration. Blood samples will be drawn into plastic clot blood tubes and will be wrapped with aluminum foil for protection from light. Then, blood will be centrifuged at 3000 rpm for 15 minutes, serum will be separated immediately into dark cryovials and stored at -20 ◦c.
- Conditions
- Vitamin A Status
- Being tested
- Vitamin A fortified rice, Normal rice
- Keywords
- fortified rice, lactating women, 13C2-retinol isotope dilution, vitamin A liver store
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin A fortified riceOther
Lactating women will receive fortified rice one meal per day on weekdays for a period of 14 weeks.
Normal riceOther
Lactating women will receive normal rice one meal per day on weekdays for a period of 14 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Fortified rice | Experimental | Participant will be given vitamin A fortified rice 1 meal/day Receives: Other: Vitamin A fortified rice |
| Control | Placebo comparator | Participant will be given normal rice 1 meal/day Receives: Other: Normal rice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin A liver store
vitamin A concentration per gram liver
Measured: 135 days
Secondary outcomes (2)
Breast milk retinol
vitamin A (retinol) concentration in breast milk
Measured: 135 days
Serum retinol
Concentration of retinol in serum
Measured: 121 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2017
- Study start15 Mar 2017
- Primary completion31 Aug 2017
- Study completion24 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin A StatusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siwaporn Pinkaew, Prince of Songkla University
- Investigators
- Siwaporn Pinkaew, Ph.D, Principal investigator, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03056625
- Sponsor's protocol ID
- MGR5980155
- Acronym
- EVAL
- Status last verified
- Sep 2017
- First submitted
- 14 Feb 2017
- Last updated
- 20 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pinkaew S, Udomkesmalee E, Davis CR, Tanumihardjo SA. Vitamin A-fortified rice increases total body vitamin A stores in lactating Thai women measured by retinol isotope dilution: a double-blind, randomized, controlled trial. Am J Clin Nutr. 2021 May 8;113(5):1372-1380. doi: 10.1093/ajcn/nqaa418.
PubMed 33675342
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Vitamin A Fortified Rice in Lactating Thai Women
- ClinicalTrials.gov ID
- NCT03056625
- Acronym / sponsor ID
- EVAL / MGR5980155
- Conditions
- Vitamin A Status
- Keywords
- fortified rice, lactating women, 13C2-retinol isotope dilution, vitamin A liver store
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 24 Dec 2017 (estimated)
- First posted
- 17 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vitamin A deficiency (VAD) remains a public health problem that occurs in children and women. WHO estimates that 190 million preschool age children (under five years of age) and 19.1 million pregnant women have inadequate concentrations of retinol . VAD may increase risk of morbidity and mortality during childhood, pregnancy and postpartum period . In developing countries, vitamin A status in lactating women is not optimal. Even in the United States, vitamin A status of low income pregnant women is marginal. Therefore, women of reproductive age are at risk of vitamin A depletion which compromises the vitamin A status of breastfed infants. Vitamin A is transferred to milk from both retinol binding protein bound and chylomicron associated vitamin A carriers. Because of teratogenicity of vitamin A, the transfer of vitamin A from pregnant mother to the fetus is carefully controlled. This results in all infants born with very low stores of vitamin A . Therefore human milk is still the best vitamin A source for infants. The concentration of vitamin A in breast milk is highest in the first 21 days postpartum (colostrum in the first 4-6 days and transitional milk in the next 7-21 days). Breast milk vitamin A concentrations and an infant's vitamin A status are based on maternal dietary intake. Breast milk retinol concentrations are a useful tool and a unique indicator for lactating women and represents extrapolations of vitamin A status of breastfed infant.
In high risk vitamin A deficiency areas, prior recommendation for lactating women was to give two doses of 200,000 IU vitamin A within 6 weeks post-delivery . However, the lack of impact evidence of this regimen led to the WHO's withdrawal of such recommendation as a public health policy .
Food-based intervention has been regarded as a sustainable approach to improve population vitamin A status. Most recently, vitamin A-depleted sows fed high-provitamin A carotenoid maize resulted in significant increase in liver stores in nursing piglets and significant higher milk retinol concentrations than sows fed white maize that given a high-dose vitamin A supplement .
Previous efforts to fortify staples or common vehicles with vitamin A offer promising solution to prevention of vitamin A deficiency in vulnerable population . Food fortified with vitamin A has potentials to improve women's vitamin A status and to increase the vitamin A concentrations of breast milk . Rice as the most important staple food in Thailand, represents the culture of consumption and lifestyle of Thai people . Recent study in Thai school children fed with extruded rice grains fortified with zinc, iron and vitamin A every weekday for 2 months, significantly increased liver stores of vitamin A, as assessed with a stable isotope technique . Likewise, fortification of rice with vitamin A may also benefit mothers during lactation.
The outcomes of this study will be useful to guide the promotion of food-based strategies to improve vitamin A status of mother and infant during lactation.
Detailed description
Objectives To determine the efficacy of vitamin A fortified rice that gets into the breast milk of lactating mothers as determined by breast milk vitamin A concentrations, total body reserves of vitamin A via isotope dilution technique, following a 14 weeks feeding trial of lactating women.
Methodology The intervention will have two arms, vitamin A fortified rice and regular rice with 35 participants (lactating women) per group. Participants will receive one meal per day on weekdays for a period of 14 weeks. The fortified dose will be measured in the final cooked product, but we will aim to administer approximately 500 µg retinol in the rice meal. Vitamin A fortified rice is produced by extrusion technology by adding retinol into an artificial rice to be mix with the normal rice.
Data collection
- Demographic data Each participants will be asked about demographic data in the first interview. The data includes general information (age, education and occupation), socioeconomic status, number of child and duration of breastfeeding mothers, if women had a child before.
- Anthropometric data Anthropometric measurements include weight and height of participants and weight, length and head circumference of infants will be recorded in the first day and post-intervention.
- Dietary assessment At the baseline (Day 1: 3+1 week after first breastfeed), all participants will be interviewed on food consumption in the previous 24 hours for 3 times (2 weekdays and 1 weekend day). The data consist of food items, food types, food components and weight or size of consumed portions. Information from the interviews will be analyzed by INMUCAL software (Mahidol University, Thailand)
- Collection and analysis of breast milk sample Breast milk samples will be collected for vitamin A analysis. Collection of breast milk sample will be divided into two periods at the following time points which will start 3+1 week after first breastfeed.
- at baseline: Day 1 and 15
- 14 weeks post-intervention: Day 121 and 135
- Collection and analysis of blood sample The change of vitamin A status of participants will be determined by using the pair13C-retinol isotope dilution test . This involves giving the first dose of 2 µmol retinol equivalent of 13C2-retinolretinyl acetate to participants on day 1 after that the second dose (2 µmol retinol) will be given to participants on the day 121. Blood sample will be collected 4 times (Day 1, 15, 121 and 135 after 3+1 week of first breastfeed) for measuring the isotopic ratio of 13C/12C and the calculation of liver vitamin A concentration. Blood samples will be drawn into plastic clot blood tubes and will be wrapped with aluminum foil for protection from light. Then, blood will be centrifuged at 3000 rpm for 15 minutes, serum will be separated immediately into dark cryovials and stored at -20 ◦c.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fortified rice | Experimental | Other: Vitamin A fortified riceParticipant will be given vitamin A fortified rice 1 meal/day |
| Control | Placebo comparator | Other: Normal riceParticipant will be given normal rice 1 meal/day |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- free of diseases
- gestational age between 37 to 42 weeks
- willing to breastfeed for a period of 4-6 months
Key exclusion criteria (4 listed)
- Hb > 70 g/L
- Postpartum Hemorrhage
- Twin, Baby with low birth weight
- Receiving vitamin A supplement during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin A fortified riceLactating women will receive fortified rice one meal per day on weekdays for a period of 14 weeks. | Other | Fortified rice |
| Normal riceLactating women will receive normal rice one meal per day on weekdays for a period of 14 weeks. | Other | Control |
Primary outcome
Vitamin A liver store
Time frame: 135 days
vitamin A concentration per gram liver
2 secondary outcomes
Breast milk retinol
Time frame: 135 days
Serum retinol
Time frame: 121 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2017.
- Derived from this study: PubMed 33675342Pinkaew S, Udomkesmalee E, Davis CR, Tanumihardjo SA. Vitamin A-fortified rice increases total body vitamin A stores in lactating Thai women measured by retinol isotope dilution: a double-blind, randomized, controlled trial. Am J Clin Nutr. 2021 May 8;113(5):1372-1380. doi: 10.1093/ajcn/nqaa418.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siwaporn Pinkaew, Ph.D principal investigator
Prince of Songkla University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin A fortified rice and Normal rice in people with Vitamin A Status, run by Prince of Songkla University at 1 site in Thailand.
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 4 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: status not confirmed, as of the sponsor's last update on 20 Sep 2017. 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 Thailand. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Siwaporn Pinkaew, Ph.D (+66899772266, siwaporn.p@psu.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitamin A liver store (time frame: 135 days). 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 NCT03056625, which also lists 1 linked publication.
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 20 Sep 2017.