An interventional study of Biofortified cassava gari and White cassava gari in Vitamin A Deficiency, sponsored by USDA, Western Human Nutrition Research Center. Completed at 1 site in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-12.
Sponsored by USDA, Western Human Nutrition Research Center · Not applicable, Interventional, and Basic science
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Among 16 studies in Vitamin A Deficiency with a site in United States — 5 open to participants now, 6 under way, 1 of them phase 3. Vitamin A Deficiency · United States.
Among the 16 studies in Vitamin A Deficiency with a site in United States, this one is the 11th largest by enrollment of the 12 interventional ones that give a count, is one of 2 that started in 2014, is one of 6 with no phase, and was the 5th registered.
67 studies on the registry are indexed under Vitamin A Deficiency; 7 are open to participants now.
Browse Vitamin A Deficiency studies →5 of the 16 studies in Vitamin A Deficiency with a site in United States are open now. Recruiting first, the newest first:
Opus Genetics, Inc · Sites in United States
Ages 18+
University of Minnesota · Sites in United States
Ages 18–60 · Healthy volunteers
Children's Hospital Medical Center, Cincinnati · Sites in United States
Ages 18+
MD Stem Cells · Sites in United States, Austria, United Arab Emirates
Ages 18+
University of Mississippi Medical Center · Sites in United States
Ages 18–45
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 6 Vitamin A Deficiency studies recruiting now, 3 set no upper age limit and 3 stop at 75 or younger; 2 take children under 18; 2 take healthy volunteers.
This study: 18 Years to 45 Years · female · healthy volunteers too.
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16 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 2 started in 2014.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 10 is below the median of 200 across 49 interventional studies indexed under Vitamin A Deficiency.
Median enrollment 86 across the 12 interventional studies, 48 across the 4 observational. Of the 10 that completed or were terminated, 2 (20%) have results posted.
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3 of 16 have an industry lead sponsor. The 10 most frequent:
USDA, Western Human Nutrition Research Center is the lead sponsor of 54 studies on the registry; 1 is open to participants now.
USDA, Western Human Nutrition Research Center has 5 studies filed under Vitamin A Deficiency — fewer than ten, so there is no comparison to draw.
4 of the studies in Vitamin A Deficiency with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07140783Phase 3Opus Genetics, IncOPI-NXYDLD-303 Safety and Efficacy of Phentolamine Ophthalmic Solution in Keratorefractive Surgery Participants With Decreased Mesopic Visual Acuity | 2027-08 |
| NCT07736768University of Mississippi Medical CenterVitamin A Supplementation and Breast Milk Vitamin A Levels in Mothers of Preterm Infants | 2027-07-30 |
| NCT03011541MD Stem CellsStem Cell Ophthalmology Treatment Study II | 2027-07-31 |
| NCT06450925Children's Hospital Medical Center, CincinnatiVitamin A Supplementation in Allogeneic Stem Cell Transplantation. | 2027-08 |
Add all 4 to your calendar (.ics) → With an account.
Among the 16 studies in Vitamin A Deficiency with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The goal of the research study is to determine the absorption, metabolism, and bioconversion of carotenoids such as beta-carotene to vitamin A from gari made with biofortified cassava compared to a mixture of red palm oil and gari made from typical white cassava.
Vitamin A deficiency (VAD) is a major public health problem in most of the developing world, especially Southern Asia and Sub-Saharan Africa. The primary issue in vitamin A deficient populations is the low vitamin A content of the diet. Beta-carotene is the most abundant provitamin A carotenoid in nature and in human tissues. Increasing the concentrations of bioavailable vitamin A-forming carotenoids in staple foods by selective breeding is a good strategy for improving vitamin A status. Cassava, bred to contain high amounts of vitamin A-forming carotenoids is one such food, since it is a staple crop in Africa and parts of South America. A popular cassava product Africa is gari, which is fermented, dewatered, milled, and roasted so that it can be used for porridges and in baking. However, the effect of feeding biofortified gari meals on carotenoid and vitamin A concentrations in the body is not known. A common practice is to add red palm oil to typical white cassava gari. Red palm oil is a very rich source of alpha-carotene and beta-carotene, in highly bioavailable forms. Unfortunately, little is known of the bioconversion of red palm oil cassava mixture carotenoids to vitamin A.
The primary purpose of this study is to determine the effect of consuming gari that is made from biofortified cassava on carotenoid and vitamin A concentrations. The investigators will compare carotenoid and vitamin A concentrations in individuals fed biofortified gari to the same individuals fed gari made from ordinary cassava. The investigators hypothesis is that the biofortified gari will increase carotenoid and vitamin A concentrations in triacylglycerol-rich plasma (TRL). The secondary purpose of this study is to investigate the effect of a meal of high carotenoid red palm oil added to typical white gari on carotenoids and vitamin A. Adding red palm oil to white gari should be an effective method for increasing carotenoids and vitamin A status in the gari meal, and thus humans. The investigators will match the amount of retinol equivalents in the biofortified cassava gari and red palm oil-containing white cassava gari. This will let us compare their effectiveness at increasing carotenoid and vitamin A concentrations in the TRL plasma fraction after consumption. This will allow us to compare their bioavailability and bioconversion efficiencies.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A single meal containing 400 gm of garified non-biofortified (white) cassava with retinyl palmitate reference dose.
Other: White cassava gari
A single meal containing 400 gm of garified non-biofortified (white) cassava with red palm oil.
Other: White cassava gari + red palm oil
A single meal containing 400 gm of garified biofortified cassava.
Other: Biofortified cassava gari
Cassava, bred to contain high amounts of vitamin A-forming carotenoids (primarily beta-carotene and its cis-derivatives).
Non-biofortified (white) cassava and a retinyl palmitate reference dose.
Non-biofortified (white) cassava gari containing red palm oil.
Change in vitamin A in triacylglycerol-rich lipoprotein (TRL) fraction of plasma
Vitamin A is measured by standard methods involving ultracentrifugation (to concentrate the TRL fraction) followed by reversed-phase high pressure liquid chromatography (HPLC) using electrochemical detection.
Time frame: 2, 3.5, 5, 7.25, and 9.5 hours after a meal
Change in carotenoids in triacylglycerol-rich lipoprotein (TRL) fraction of plasma
Carotenoids will be measured by standard methods involving ultracentrifugation (to concentrate the TRL fraction) followed by reversed-phase HPLC using electrochemical detection.
Time frame: 2, 3.5, 5, 7.25, and 9.5 hours after a meal
The record gives a start of Jul 2014, a primary completion of Dec 2014 and a completion of Dec 2014. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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USDA, Western Human Nutrition Research Center