An observational study in Environmental Enteric Dysfunction, Zinc Deficiency and Vitamin A Deficiency, sponsored by University of Colorado, Denver. Completed at 2 sites in 2 countries. Open to participants aged 18 Months to 24 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-01.
Sponsored by University of Colorado, Denver · Observational
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 one of 2 that started in 2015, is one of 4 observational ones, and was the 6th 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 Months to 24 Months · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
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 2015.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 46 is below the median of 258 across 17 observational 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:
University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
University of Colorado, Denver has 1 study 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 overall objective is to determine the impact of EED on zinc absorption and homeostasis, and its impact on the absorptive capacity of vitamin A absorption of young children (18-24 months of age) in an austere setting with high rates of diarrhea, stunting, and micro-nutrient deficiencies.
Participating children are screened for EED using the lactulose:mannitol ratio test and assigned to one of two groups: +EED or -EED. All participants will be given standard, physiological dose of 3 mg zinc sulfate with a zinc stable isotope tracer on study day 8.
On study day 11, 0.5 mg of 13C10-retinyl-acetate will be administered orally to all participants.
Spot urine samples will be collected twice daily from study days 11-14. Complete fecal collections will be obtained for days 11-14. Duplicate diets of all foods consumed will be collected on days 11-14. On study day 14, a blood sample will be taken for analysis of vitamin A isotope status.
Toddlers aged 18-24 mos living in Dhaka, Bangladesh
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.
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).
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.
Children are placed in this arm if they screen positive for EED using the urinary lactulose:mannitol (L:M) recovery ratio. Children will receive a one-time 3 mg standard dose of zinc sulfate with stable isotope zinc tracer and 0.5 mg standard dose of 13C10-retinyl-acetate (vitamin A isotope).
Drug: 3 mg zinc sulfate supplement · Drug: 0.5 mg of 13C10-retinyl-acetate
Children are placed in this arm if they screen negative for EED using the urinary lactulose:mannitol (L:M) recovery ratio. Children will receive a one-time 3 mg standard dose of zinc sulfate with stable isotope zinc tracer and 0.5 mg standard dose of 13C10-retinyl-acetate (vitamin A isotope).
Drug: 3 mg zinc sulfate supplement · Drug: 0.5 mg of 13C10-retinyl-acetate
Also known as: Vitamin A isotope
Absorption of zinc (AZ) from standard dose
Absorption of zinc from standard 3 mg dose will be measured using zinc isotope tracer methods
Time frame: 1 day
Endogenous fecal zinc (EFZ)
EFZ measured from zinc isotope ratios in complete fecal collections
Time frame: 4 days
Vitamin A absorption
Absorption efficiency of retinol will be measured by isotope ratios in blood
Time frame: 1 day
Plasma zinc
Plasma zinc concentration
Time frame: 1 day
Alkaline phosphatase
Time frame: 1 day
Serum retinol
Time frame: 1 day
Methyl malonic acid
serum
Time frame: 1 day
Vitamin B12
Time frame: 1 day
Serum ferritin
Time frame: 1 day
Soluble transferrin receptors
Time frame: 1 day
C-reactive Protein (CRP)
Time frame: 1 day
Alpha-Glycoprotein (AGP)
Time frame: 1 day
Tumor necrosis factor (TNF) alpha
Time frame: 1 day
Serum endocab
Time frame: 1 day
Fecal neopterin
Time frame: 1 day
Myeloperoxidase
Time frame: 1 day
Alpha 1 antitrypsin
Time frame: 1 day
Calprotectin
Time frame: 1 day
Plan to share: No
Ran from Nov 2015 to primary completion in Jun 2017, 19 months.
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This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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University of Colorado, Denver →