Folic Acid DeficiencyFolatefoodNCT02373033
Folate-Rich Foods Improve Folate Status
A study testing Natural food folate, Folic acid and Apple juice in people with Folic Acid Deficiency, run by Mansoura University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 32 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Folic Acid Deficiency
- What is being tested?
- Natural food folate, Folic acid and Apple juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2013to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 32 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal biochemical range for:
- Fasted plasma glucose
- Iron status (haemoglobin, serum ferritin)
- Liver status (aspartate transaminase, alanine transaminase, and γ-glutamyl transferase activities)
- Lipid profile (triglycerides, LDL, HDL)
- Folate status (plasma and erythrocyte folate)
- Plasma total homocysteine (tHcy)
- Vitamin B-12
Who cannot join
- History of acute or chronic disease
- Use of vitamin or mineral supplements or folic acid fortified foods (within the past one month)
- A body mass index (BMI, in kg/m2) >18 and <30
- Any medication interfering with folate metabolism (e.g., antiepileptic drugs, antibiotics, methotrexate, sulfasalazine, or anticonvulsants), smokers, consuming special diets (vegetarian), pregnancy, planned conception or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of a 3-months Dietary Intervention With Folate Enhanced Foods on Folate Status in Healthy Egyptian Women
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.
Read the detailed description
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.
- Conditions
- Folic Acid Deficiency
- Being tested
- Natural food folate, Folic acid, Apple juice
- Keywords
- Folate, folic acid, intervention trial, folate status, women in childbearing age, food folate
- Medical subject headings
- Folic Acid Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natural food folateOther
Also called Food folate
Consumed folate-rich foods (providing additional 250 μg/d folate).
Folic acidOther
Received a folic acid supplement (providing additional 500 μg/d folic acid).
Apple juiceOther
Received apple juice containing no folate or folic acid.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Natural food folate | Active comparator | Food group consumed folate-rich foods (providing additional 250 μg/d folate). Receives: Other: Natural food folate |
| Intervention: Folic acid | Active comparator | Folic acid group received a folic acid supplement (providing additional 500 μg/d folic acid). Receives: Other: Folic acid |
| Intervention: Control | Placebo comparator | Control group received apple juice containing no folate or folic acid every day. Receives: Other: Apple juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma folate
Assessment of plasma folate at baseline, 8 and 12 weeks
Measured: (0 and 12 weeks)
Change in erythrocyte folate
Assessment of erythrocyte folate at baseline, 8 and 12 weeks
Measured: (0 and 12 weeks)
Secondary outcomes (1)
Change in plasma total homocysteine
Assessment of plasma total homocysteine at baseline, 8 and 12 weeks
Measured: (0 and 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startMar 2013
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Folic Acid DeficiencyStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish University of Agricultural Sciences, The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)
- Responsible party
- Principal investigator, Mohammed Hefni, Mansoura University
- Investigators
- Cornelia Witthöft, Prof, Principal investigator, Dept of Food Science, Swedish University of Agricultural Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02373033
- Sponsor's protocol ID
- Formas Sida Dn 222-2009-1975
- Acronym
- Folatefood
- Status last verified
- Feb 2015
- First submitted
- 3 Feb 2015
- Last updated
- 26 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ohrvik VE, Olsson JC, Sundberg BE, Witthoft CM. Effect of 2 pieces of nutritional advice on folate status in Swedish women: a randomized controlled trial. Am J Clin Nutr. 2009 Apr;89(4):1053-8. doi: 10.3945/ajcn.2008.27192. Epub 2009 Feb 3.
PubMed 19190070
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a 3-months Dietary Intervention With Folate Enhanced Foods on Folate Status in Healthy Egyptian Women
- ClinicalTrials.gov ID
- NCT02373033
- Acronym / sponsor ID
- Folatefood / Formas Sida Dn 222-2009-1975
- Conditions
- Folic Acid Deficiency
- Keywords
- Folate, folic acid, intervention trial, folate status, women in childbearing age, food folate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Collaborators
- Swedish University of Agricultural Sciences, The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)
- Study start
- Mar 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 26 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention: Natural food folate | Active comparator | Other: Natural food folateFood group consumed folate-rich foods (providing additional 250 μg/d folate). |
| Intervention: Folic acid | Active comparator | Other: Folic acidFolic acid group received a folic acid supplement (providing additional 500 μg/d folic acid). |
| Intervention: Control | Placebo comparator | Other: Apple juiceControl group received apple juice containing no folate or folic acid every day. |
Who may qualify
- Ages
- 19 to 32 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Fasted plasma glucose
- Iron status (haemoglobin, serum ferritin)
- Liver status (aspartate transaminase, alanine transaminase, and γ-glutamyl transferase activities)
- Lipid profile (triglycerides, LDL, HDL)
- Folate status (plasma and erythrocyte folate)
Key exclusion criteria (4 listed)
- History of acute or chronic disease
- Use of vitamin or mineral supplements or folic acid fortified foods (within the past one month)
- A body mass index (BMI, in kg/m2) >18 and <30
- Any medication interfering with folate metabolism (e.g., antiepileptic drugs, antibiotics, methotrexate, sulfasalazine, or anticonvulsants), smokers, consuming special diets (vegetarian), pregnancy, planned conception or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Natural food folateAlso: Food folateConsumed folate-rich foods (providing additional 250 μg/d folate). | Other | Intervention: Natural food folate |
| Folic acidReceived a folic acid supplement (providing additional 500 μg/d folic acid). | Other | Intervention: Folic acid |
| Apple juiceReceived apple juice containing no folate or folic acid. | Other | Intervention: Control |
Primary outcome
Change in plasma folate
Time frame: (0 and 12 weeks)
Assessment of plasma folate at baseline, 8 and 12 weeks
Change in erythrocyte folate
Time frame: (0 and 12 weeks)
Assessment of erythrocyte folate at baseline, 8 and 12 weeks
1 secondary outcome
Change in plasma total homocysteine
Time frame: (0 and 12 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2015.
- Results publication: PubMed 19190070Ohrvik VE, Olsson JC, Sundberg BE, Witthoft CM. Effect of 2 pieces of nutritional advice on folate status in Swedish women: a randomized controlled trial. Am J Clin Nutr. 2009 Apr;89(4):1053-8. doi: 10.3945/ajcn.2008.27192. Epub 2009 Feb 3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cornelia Witthöft, Prof principal investigator
Dept of Food Science, Swedish University of Agricultural Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Natural food folate, Folic acid and Apple juice in people with Folic Acid Deficiency, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in plasma folate (time frame: (0 and 12 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02373033, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2015.