An interventional study of thiamine (as thiamine hydrochloride) in Thiamine Deficiency, sponsored by Mount Saint Vincent University. Completed at 1 site in Cambodia. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2021-02-24.
Sponsored by Mount Saint Vincent University · Not applicable, Interventional, and Prevention
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.
(see full protocol)
18 studies on the registry are indexed under Thiamine Deficiency; 1 is open to participants now.
This study's enrollment of 335 is above the median of 52 across 13 interventional studies indexed under Thiamine Deficiency.
Browse Thiamine Deficiency studies →Mount Saint Vincent University is the lead sponsor of 14 studies on the registry; 1 is open to participants now.
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Mothers of a newborn who:
Exclusion Criteria:
Mothers of a newborn who:
placebo; 0 mg thiamine
Dietary Supplement: thiamine (as thiamine hydrochloride)
1.2 mg thiamine as thiamine hydrochloride
Dietary Supplement: thiamine (as thiamine hydrochloride)
2.4 mg thiamine as thiamine hydrochloride
Dietary Supplement: thiamine (as thiamine hydrochloride)
10 mg thiamine as thiamine hydrochloride
Dietary Supplement: 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).
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.
Time frame: 24 weeks postpartum
Infant thiamine diphosphate concentrations (ThDP)
To estimate the dose on the dose response curve where additional maternal intake of thiamine (oral dose) no longer meaningfully increases infant thiamine diphosphate concentrations (ThDP) 24 weeks postnatally, and assess whether this depends on the presence/absence of a genetic hemoglobin disorder.
Time frame: 24 weeks postnatal
Human milk total thiamine concentrations
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 4 and 12 weeks postpartum.
Time frame: 4 and 12 weeks postpartum
Infant transketolase activity
To estimate the dose on the dose response curve where additional maternal intake of thiamine (oral dose) no longer meaningfully increases infant transketolase activity at 24 weeks postnatally, and assess whether this depends on the presence/absence of a genetic hemoglobin disorder.
Time frame: 24 weeks postnatal
Maternal ThDP (dose response)
To estimate the dose on the dose response curve where additional maternal intake of thiamine (oral dose) no longer meaningfully increases maternal ThDP at 24 weeks postpartum, and assess whether this depends on the presence/absence of a genetic hemoglobin disorder.
Time frame: 24 weeks postpartum
Maternal transketolase activity (dose response)
To estimate the dose on the dose response curve where additional maternal intake of thiamine (oral dose) no longer meaningfully increases maternal ETKac at 24 weeks postpartum, and assess whether this depends on the presence/absence of a genetic hemoglobin disorder.
Time frame: 24 weeks postpartum
Human milk total thiamine concentrations
To test for differences between the 4 randomized groups on human milk total thiamine at 4, 12, and 24 weeks postpartum.
Time frame: 4, 12, and 24 weeks postpartum
Maternal ThDP (by arm)
To test for differences between the 4 randomized groups on maternal ThDP at 24 weeks postpartum, and assess whether this depends on the presence/absence of genetic hemoglobin disorder.
Time frame: 24 weeks postpartum
Maternal transketolase activity (by arm)
To test for differences between the 4 randomized groups on maternal ETKac at 24 weeks postpartum and assess whether this depends on the presence/absence of a genetic hemoglobin disorder.
Time frame: 24 weeks postpartum
Household salt intake
To estimate usual household salt intake from mean fortnightly salt disappearance (weight lost, in g).
Time frame: within 2 and 24 weeks postpartum
Salt intake of household members
To estimate salt intake among a subset of 100 lactating women, their male partners (if applicable), and their children 24-59 months (if applicable) using observed weighed salt intake records.
Time frame: within 2 and 24 weeks postpartum
Sodium intake of women
To estimate sodium intake using 24 hr urinary sodium concentrations among a subset of 100 lactating women.
Time frame: within 2 and 24 weeks postpartum
Mullen scores
To test for differences between the 0 \& 10 mg randomized groups on Composite Mullen and the 5 subscales of the Mullen at 24 and 52 weeks postnatally. Score notes for Mullen Scales of Early Learning Gross Motor Scale: Raw score range: 0-36 (higher scores reflect better performance) Visual Reception Scale: Raw score range: 0-50 (higher scores reflect better performance) Fine Motor Scale: Raw score range: 0-49 (higher scores reflect better performance) Receptive Language Scale: Raw score range: 0-48 (higher scores reflect better performance) Expressive Language Scale: Raw score range: 0-50 (higher scores reflect better performance) All raw scores are converted to age-adjusted T-scores (provided by manual). An optional Early Learning Composite Score can be calculated by summing the T-scores of all but the Gross Motor Scale.
Time frame: 24 and 52 weeks postnatal
Visual paired comparison
To test for differences between the 0 \& 10 mg randomized groups on Visual Paired Comparison Novelty Score and the attention and processing speed subscales at 24 and 52 weeks postnatally. Score notes for Visual Paired Comparison task Scale ranges: An overall novelty score is calculated that averages across all face and pattern trials, and is a percentage reflecting the percent of time infants' looked at the novel item during the test phase, calculated as the duration looking to the novel item divided by the sum of the duration of looking to the novel item plus the duration looking to the familiar item. Sub-scales: Two sub-scales are calculated: the novelty score averaged across face trials, and the novelty score averaged across pattern trials. The total scale composite averages the novelty score across the two sub-scales. For all scales, he range is 0-100%, and higher novelty scores indicate better outcomes.
Time frame: 24 and 52 weeks postnatal
Language Preference Task
To test for differences between the 0 \& 10 mg randomized groups on the Language Preference Task Score at 24 weeks postnatally.
Time frame: 24 weeks postnatal
Oculomotor scores
To test for differences between 0 \& 10 mg randomized groups on oculomotor scores at 24 weeks postnatally. Score notes for the Oculomotor Test: The proposed oculomotor test is not a single, published instrument, but instead, combines several standard screening items. Strabismus: absent or present; score: 0-1 Nystagmus: absent or present; score: 0-1 Amblyopia: absent or present; score 0-1 Saccade: * guided saccade: absent or present; score 0-1 * scanning: absent or present; score 0-1 * predicted saccade: absent or present; score 0-1 Smooth pursuit: * overall pursuit: absent or present; score 0-1 * horizontal pursuit: score 0-1 * vertical pursuit: score 0-1 Total oculomotor score (optional): sum of all scored exam items: range 0-9
Time frame: 24 weeks postnatal
Inflammation
To determine the effect of inflammation, as measured by C-reactive protein (CRP) and α-1-acid-glycoprotein (AGP) on maternal ThDP at 2 and 24 weeks postpartum, and infant ThDP at 24 weeks postnatal.
Time frame: 24 weeks postnatal
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Aug 2018 to primary completion in May 2020, 20 months.
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Studies of the drug tested here: Thiamine
Mount Saint Vincent University