Thiamine DeficiencyNCT03616288
Trial of Thiamine Supplementation in Cambodia
A study testing thiamine (as thiamine hydrochloride) in people with Thiamine Deficiency, run by Mount Saint Vincent University at 1 site in Cambodia.
Trial summary
Beriberi is a potentially fatal disease caused by vitamin B1 (thiamine) deficiency that still occurs in Southeast Asia despite near eradication elsewhere. Mothers with a diet low in thiamine produce thiamine-poor milk, putting their infants at a high risk of developing thiamine deficiency and beriberi. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Thiamine Deficiency
- What is being tested?
- thiamine (as thiamine hydrochloride)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 335 participants
- Where
- 1 siteCambodia
- Study dates
- 28 Aug 2018to 28 Jan 2021
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Mothers of a newborn who:
- are aged 18 - 45 years
- had a recent normal pregnancy (i.e. no known chronic conditions, no preeclampsia, gestational diabetes etc), and the singleton infant was born without complications (e.g. low birth weight (<2.5 kg), tongue tie, cleft palate)
- are intending to exclusively breastfeed for six months
- reside in Kampong Thom province, Cambodia, and are not planning to move in the next six months
- are willing to consume one capsule daily from 2 weeks through to 24 weeks postpartum
- are willing for her entire household consume only salt provided by the study team
- are willing for the following biological samples to be collected: a maternal venous blood sample and human milk sample at 2 weeks postpartum, a human milk sample at 4 and 12 weeks postpartum, and maternal and infant blood samples and a human milk sample at 24 weeks postpartum.
Who cannot join
- Mothers of a newborn who:
- are currently taking or has taken thiamine-containing supplements over the past 4 months
- are currently participating in nutrition programs beyond normal care
Trial locations and contacts
1 site in 1 country.
Cambodia1 site
Helen Keller International
Kampong Thom, Kapmong Thom Province
About this study
Official title: Improving Estimates of the Global Burden of Thiamine Deficiency Disorders and Approaches to Their Control: Trial of Thiamine Supplementation in Cambodia
Beriberi is a potentially fatal disease caused by vitamin B1 (thiamine) deficiency that still occurs in Southeast Asia despite near eradication elsewhere. Mothers with a diet low in thiamine produce thiamine-poor milk, putting their infants at a high risk of developing thiamine deficiency and beriberi. There is also a growing body of evidence suggesting thiamine deficiency not severe enough to cause clinical symptoms may negatively effect cognitive development and functioning of the infant. Since human milk should be the sole source of nutrition for babies during the first six months, maternal thiamine intake must be improved to combat this disease.
The investigators' recent study of thiamine-fortified fish sauce in Cambodia showed that fortification could increase maternal and infant thiamine status'. However, centrally produced fish sauce may not reach the poorest communities who make their own fish sauce, and fish sauce is not consumed in all regions where we find thiamine deficiency. Salt, by contrast, is a common condiment in most regions of the world and has proven to be a successful global fortification vehicle for iodine.
Suboptimal maternal thiamine intake puts exclusively breastfed infants at risk of low thiamine status, impaired cognitive development, and infantile beriberi, which can be fatal. Thiamine fortification of salt is a potentially low-cost and sustainable means of combating suboptimal thiamine status; however knowledge gaps must be filled before thiamine fortification can proceed. In this study, mothers will consume thiamine supplements in order to model the thiamine dose required to optimize human milk thiamine concentrations for the prevention of beriberi. Other thiamine biomarkers will be assessed, and usual salt intake will be measured. Finally, the investigators will assess the effects of early-life thiamine exposure on infant neuro-cognitive development.
Read the detailed description
(see full protocol)
- Conditions
- Thiamine Deficiency
- Being tested
- thiamine (as thiamine hydrochloride)
- Medical subject headings
- Thiamine Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thiamine (as thiamine hydrochloride)Dietary supplement
Opaque capsules containing varying amounts of thiamine hydrochloride and cellulose filler. All thiamine is delivered as thiamine hydrochloride, calculated using a 1.271 correction factor (ratio of molecular weights of thiamine hydrochloride and thiamine).
| Study group | Role | What they receive |
|---|---|---|
| Negative Control | Placebo comparator | placebo; 0 mg thiamine Receives: Dietary Supplement: thiamine (as thiamine hydrochloride) |
| EAR Group | Experimental | 1.2 mg thiamine as thiamine hydrochloride Receives: Dietary Supplement: thiamine (as thiamine hydrochloride) |
| Double EAR Group | Experimental | 2.4 mg thiamine as thiamine hydrochloride Receives: Dietary Supplement: thiamine (as thiamine hydrochloride) |
| Positive Control | Experimental | 10 mg thiamine as thiamine hydrochloride Receives: Dietary Supplement: thiamine (as thiamine hydrochloride) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Human milk total thiamine concentration
To estimate the dose on the dose response curve where additional maternal intake of thiamine (oral dose) no longer meaningfully increases human milk total thiamine concentration at 24 weeks postpartum.
Measured: 24 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start28 Aug 2018
- Primary completion5 May 2020
- Study completion28 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Thiamine DeficiencyStudies 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
- Model description
- Randomized placebo controlled, double-blinded, four-parallel arm, multicentre trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 335 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Saint Vincent University
- Sponsor type
- University, hospital or other
- Collaborators
- Sackler Institute for Nutrition Science, Bill and Melinda Gates Foundation, Helen Keller International, NCHADS - Ministry of Health of Cambodia, Ministry of Planning, Cambodia, South Australian Health and Medical Research Institute, Institut de Recherche pour le Developpement, University of Oregon
- Responsible party
- Principal investigator, Kyly Whitfield, Mount Saint Vincent University
- Investigators
- Kyly C Whitfield, PhD, Principal investigator, Mount Saint Vincent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03616288
- Sponsor's protocol ID
- MSVUREB2017-141
- Other IDs
- 112NECHR
- Status last verified
- Feb 2021
- First submitted
- 31 Jul 2018
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Baldwin DA, Measelle J, Gallivan L, Sanchirico A, Weinstein N, Bala A, Chan K, Gallant J, Borath M, Kroeun H, Wieringa FT, Green TJ, Whitfield KC. Language processing in breastfed infants at risk of thiamine deficiency benefits from maternal thiamine supplementation. Dev Psychol. 2025 Aug;61(8):1427-1440. doi: 10.1037/dev0001829. Epub 2024 Dec 19.
PubMed 39699595Gallant J, Chan K, Green TJ, Wieringa FT, Leemaqz S, Ngik R, Measelle JR, Baldwin DA, Borath M, Sophonneary P, Yelland LN, Hampel D, Shahab-Ferdows S, Allen LH, Jones KS, Koulman A, Parkington DA, Meadows SR, Kroeun H, Whitfield KC. Low-dose thiamine supplementation of lactating Cambodian mothers improves human milk thiamine concentrations: a randomized controlled trial. Am J Clin Nutr. 2021 Jul 1;114(1):90-100. doi: 10.1093/ajcn/nqab052.
PubMed 33829271Whitfield KC, Kroeun H, Green T, Wieringa FT, Borath M, Sophonneary P, Measelle JR, Baldwin D, Yelland LN, Leemaqz S, Chan K, Gallant J. Thiamine dose response in human milk with supplementation among lactating women in Cambodia: study protocol for a double-blind, four-parallel arm randomised controlled trial. BMJ Open. 2019 Jul 9;9(7):e029255. doi: 10.1136/bmjopen-2019-029255.
PubMed 31292183
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Estimates of the Global Burden of Thiamine Deficiency Disorders and Approaches to Their Control: Trial of Thiamine Supplementation in Cambodia
- ClinicalTrials.gov ID
- NCT03616288
- Acronym / sponsor ID
- MSVUREB2017-141
- Conditions
- Thiamine Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 335 participants (actual)
- Lead sponsor
- Mount Saint Vincent UniversityUniversity, hospital or other
- Collaborators
- Sackler Institute for Nutrition Science, Bill and Melinda Gates Foundation, Helen Keller International, NCHADS - Ministry of Health of Cambodia, Ministry of Planning, Cambodia, South Australian Health and Medical Research Institute, Institut de Recherche pour le Developpement, University of Oregon
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- 5 May 2020 (actual)
- Study completion
- 28 Jan 2021 (actual)
- First posted
- 6 Aug 2018 (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.
Beriberi is a potentially fatal disease caused by vitamin B1 (thiamine) deficiency that still occurs in Southeast Asia despite near eradication elsewhere. Mothers with a diet low in thiamine produce thiamine-poor milk, putting their infants at a high risk of developing thiamine deficiency and beriberi. There is also a growing body of evidence suggesting thiamine deficiency not severe enough to cause clinical symptoms may negatively effect cognitive development and functioning of the infant. Since human milk should be the sole source of nutrition for babies during the first six months, maternal thiamine intake must be improved to combat this disease.
The investigators' recent study of thiamine-fortified fish sauce in Cambodia showed that fortification could increase maternal and infant thiamine status'. However, centrally produced fish sauce may not reach the poorest communities who make their own fish sauce, and fish sauce is not consumed in all regions where we find thiamine deficiency. Salt, by contrast, is a common condiment in most regions of the world and has proven to be a successful global fortification vehicle for iodine.
Suboptimal maternal thiamine intake puts exclusively breastfed infants at risk of low thiamine status, impaired cognitive development, and infantile beriberi, which can be fatal. Thiamine fortification of salt is a potentially low-cost and sustainable means of combating suboptimal thiamine status; however knowledge gaps must be filled before thiamine fortification can proceed. In this study, mothers will consume thiamine supplements in order to model the thiamine dose required to optimize human milk thiamine concentrations for the prevention of beriberi. Other thiamine biomarkers will be assessed, and usual salt intake will be measured. Finally, the investigators will assess the effects of early-life thiamine exposure on infant neuro-cognitive development.
Detailed description
(see full protocol)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Randomized placebo controlled, double-blinded, four-parallel arm, multicentre trial
| Arm | Type | Receives |
|---|---|---|
| Negative Control | Placebo comparator | Dietary Supplement: thiamine (as thiamine hydrochloride)placebo; 0 mg thiamine |
| EAR Group | Experimental | Dietary Supplement: thiamine (as thiamine hydrochloride)1.2 mg thiamine as thiamine hydrochloride |
| Double EAR Group | Experimental | Dietary Supplement: thiamine (as thiamine hydrochloride)2.4 mg thiamine as thiamine hydrochloride |
| Positive Control | Experimental | Dietary Supplement: thiamine (as thiamine hydrochloride)10 mg thiamine as thiamine hydrochloride |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- are aged 18 - 45 years
- had a recent normal pregnancy (i.e. no known chronic conditions, no preeclampsia, gestational diabetes etc), and the singleton infant was born without complications (e.g. low birth weight (<2.5 kg), tongue tie, cleft palate)
- are intending to exclusively breastfeed for six months
- reside in Kampong Thom province, Cambodia, and are not planning to move in the next six months
- are willing to consume one capsule daily from 2 weeks through to 24 weeks postpartum
Key exclusion criteria (3 listed)
- are currently taking or has taken thiamine-containing supplements over the past 4 months
- are currently participating in nutrition programs beyond normal care
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 |
|---|---|---|
| thiamine (as thiamine hydrochloride)Opaque capsules containing varying amounts of thiamine hydrochloride and cellulose filler. All thiamine is delivered as thiamine hydrochloride, calculated using a 1.271 correction factor (ratio of molecular weights of thiamine hydrochloride and thiamine). | Dietary supplement | Double EAR Group, EAR Group, Negative Control, Positive Control |
Primary outcome
Human milk total thiamine concentration
Time frame: 24 weeks postpartum
To estimate the dose on the dose response curve where additional maternal intake of thiamine (oral dose) no longer meaningfully increases human milk total thiamine concentration at 24 weeks postpartum.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- Derived from this study: PubMed 39699595Baldwin DA, Measelle J, Gallivan L, Sanchirico A, Weinstein N, Bala A, Chan K, Gallant J, Borath M, Kroeun H, Wieringa FT, Green TJ, Whitfield KC. Language processing in breastfed infants at risk of thiamine deficiency benefits from maternal thiamine supplementation. Dev Psychol. 2025 Aug;61(8):1427-1440. doi: 10.1037/dev0001829. Epub 2024 Dec 19.
- Derived from this study: PubMed 33829271Gallant J, Chan K, Green TJ, Wieringa FT, Leemaqz S, Ngik R, Measelle JR, Baldwin DA, Borath M, Sophonneary P, Yelland LN, Hampel D, Shahab-Ferdows S, Allen LH, Jones KS, Koulman A, Parkington DA, Meadows SR, Kroeun H, Whitfield KC. Low-dose thiamine supplementation of lactating Cambodian mothers improves human milk thiamine concentrations: a randomized controlled trial. Am J Clin Nutr. 2021 Jul 1;114(1):90-100. doi: 10.1093/ajcn/nqab052.
- Derived from this study: PubMed 31292183Whitfield KC, Kroeun H, Green T, Wieringa FT, Borath M, Sophonneary P, Measelle JR, Baldwin D, Yelland LN, Leemaqz S, Chan K, Gallant J. Thiamine dose response in human milk with supplementation among lactating women in Cambodia: study protocol for a double-blind, four-parallel arm randomised controlled trial. BMJ Open. 2019 Jul 9;9(7):e029255. doi: 10.1136/bmjopen-2019-029255.
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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.
Kyly C Whitfield, PhD principal investigator
Mount Saint Vincent 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 thiamine (as thiamine hydrochloride) in people with Thiamine Deficiency, run by Mount Saint Vincent University at 1 site in Cambodia.
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 8 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 24 Feb 2021. 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 Cambodia. 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?
Human milk total thiamine concentration (time frame: 24 weeks postpartum). 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 NCT03616288, which also lists 3 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 24 Feb 2021.