An interventional study of Natural food folate and Folic acid in Folic Acid Deficiency, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to female participants aged 19 Years to 32 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-02-26.
Sponsored by Mansoura University · Not applicable, Interventional, and Basic science
This study evaluates the effects of folate-rich foods regarding improvement of folate status compared with folic acid supplement. A randomized, parallel intervention trial with two active groups (folate-rich foods or folic acid supplement) and one control group (apple juice - 0 µg/d folate) was executed over 12 weeks.
Sixty-two women in reproductive age, apparently healthy, non-smokers, not consuming special diets (vegetarian), not pregnant, not planning conception or not lactating.
A randomized, controlled, parallel intervention trial with two active groups and one blinded control group was carried out for 12 weeks (March to June, 2013). The active food group (n = 21) consumed folate-rich foods (germinated canned faba beans, cookies, orange juice, providing additional 250 μg/d folate); the active folic acid supplement group consumed a supplement (n = 19, providing 500 μg/d folic acid); and the control group (n = 22) received apple juice containing no folate or folic acid) in addition to the freely chosen diet.
Fasted venous blood samples were collected at baseline, two months and three months for quantification of folate in plasma and erythrocytes and of homocysteine in plasma.
35 studies on the registry are indexed under Folic Acid Deficiency; 4 are open to participants now.
This study's enrollment of 57 is below the median of 170 across 16 interventional studies indexed under Folic Acid Deficiency.
Browse Folic Acid Deficiency studies →Mansoura University is the lead sponsor of 1,115 studies on the registry; 184 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Normal biochemical range for:
Exclusion Criteria:
Food group consumed folate-rich foods (providing additional 250 μg/d folate).
Other: Natural food folate
Folic acid group received a folic acid supplement (providing additional 500 μg/d folic acid).
Other: Folic acid
Control group received apple juice containing no folate or folic acid every day.
Other: Apple juice
Consumed folate-rich foods (providing additional 250 μg/d folate).
Also known as: Food folate
Received a folic acid supplement (providing additional 500 μg/d folic acid).
Received apple juice containing no folate or folic acid.
Change in plasma folate
Assessment of plasma folate at baseline, 8 and 12 weeks
Time frame: (0 and 12 weeks)
Change in erythrocyte folate
Assessment of erythrocyte folate at baseline, 8 and 12 weeks
Time frame: (0 and 12 weeks)
Change in plasma total homocysteine
Assessment of plasma total homocysteine at baseline, 8 and 12 weeks
Time frame: (0 and 12 weeks)
This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
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