An interventional study of White-fleshed sweet potatoes and Orange-fleshed sweet potatoes (boiled) in Vitamin A Deficiency, sponsored by University of California, Davis. Completed. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-30.
Sponsored by University of California, Davis · Not applicable, Interventional, and Treatment
The primary purpose of this study is to determine whether daily consumption of orange-fleshed sweet potatoes increases the vitamin A status of Bangladeshi women of reproductive age. Secondary purposes of the study are to determine whether consumption of orange-fleshed sweet potatoes has an effect on the intestinal absorption of dietary iron or dietary zinc in Bangladeshi women of reproductive age.
Biofortification of plant source foods is a promising strategy for increasing dietary vitamin A intake and vitamin A status in populations at risk of deficiency. The primary purposes of this study are:
Secondary purposes are to assess the effect of daily consumption of OFSP on intestinal absorption of iron and zinc. Specifically, 120 non-pregnant, non-lactating women at risk of vitamin A deficiency will be randomly assigned to one of the following 4 treatment groups to receive, 600 micrograms RAE/d, 6 d/wk, for 60 days as either:
The paired stable isotope dilution technique will be used to estimate total body vitamin A pool size before and after 60-days of supplementation. The efficacy of consumption of OFSP will be assessed by comparing the mean change in vitamin A pool size in the OFSP groups to the mean change in vitamin A pool size in the negative control group (WFSP group). Relative vitamin A equivalency factors will be estimated by comparing the mean change in vitamin A pool size in the OFSP groups with the mean change in vitamin A pool size in the retinyl palmitate group. Intestinal iron absorption and iron status will be assessed before and after the 60-day supplementation period in a subset of women (n=50); and intestinal zinc absorption and zinc status will be assessed after the 60-day supplementation period (n=50). Intestinal absorption of iron and zinc will be compared by treatment group to determine whether consumption of OFSP has any effect on iron or zinc absorption in these women.
67 studies on the registry are indexed under Vitamin A Deficiency; 7 are open to participants now.
This study's enrollment of 130 is below the median of 200 across 49 interventional studies indexed under Vitamin A Deficiency.
Browse Vitamin A Deficiency studies →University of California, Davis is the lead sponsor of 810 studies on the registry; 142 are open to participants now.
Of its 67 completed or terminated interventional studies of FDA-regulated products, 43 (64%) have results posted.
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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.
0 ug retinol activity equivalents (RAE)/d as boiled white-fleshed sweet potatoes (WFSP) and a corn oil capsule, 6d/wk for 10 wk
Other: White-fleshed sweet potatoes
600 ug RAE/d as boiled orange-fleshed sweet potato and a corn oil capsule, 6d/wk for 10 wk
Other: Orange-fleshed sweet potatoes (boiled)
600 ug RAE/d as fried orange-fleshed sweet potato and a corn oil capsule, 6d/wk for 10 wk
Other: Orange-fleshed sweet potatoes (fried)
0 ug RAE/d as white-fleshed sweet potato and 600 ug retinol/d as retinyl palmitate, 6d/wk for 10 wk
Other: WFSP and capsule of retinyl palmitate
Total body vitamin A pool size
Time frame: 3 years
Iron absorption
Time frame: 3 years
No study locations are listed for this record.
The record gives a start of Mar 2006, a primary completion of Dec 2009 and a completion of Dec 2009. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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