HealthyNCT02516254
Assessment of the Efficacy of Vitamin D-fortified Bread in Healthy Adults
A study testing fortified bread and supplement in people with Healthy, run by National Nutrition and Food Technology Institute.
Trial summary
The aim of this study is to evaluate the efficacy of daily intake of fortified bread with vitamin D on serum 25-hydroxyvitamin D level, glycemic and lipidemic status in healthy subjects compared to vitamin D supplement. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- fortified bread and supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Apr 2015
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 20 to 50 years
- healthy subjects
- no receiving vitamin D or omega-3 supplement in past 3 months
Who cannot join
- receiving vitamin D or omega-3 supplement during the study
About this study
Official title: Comparison of the Efficacy of Vitamin D-fortified Bread Versus Vitamin D Supplement in Healthy Adults: a Randomized Controlled Clinical Trial
The aim of this study is to evaluate the efficacy of daily intake of fortified bread with vitamin D on serum 25-hydroxyvitamin D level, glycemic and lipidemic status in healthy subjects compared to vitamin D supplement.
Read the detailed description
Sixty apparently healthy subjects will be selected. Participants who are receiving vitamin D, calcium or omega-3 supplements within the last three months will be excluded. Subjects will be assigned randomly to one of the three intervention groups: 1.fortified bread+placebo,2. plain bread+vitamin D supplements,3. plain bread+placebo. Each participant will consume 50 g of bread and supplement or placebo every day for 2 months.
At the first and last visits, dietary and laboratory assessments will be performed for all subjects. Primary outcomes are improvement in vitamin D status and secondary outcome is improvement of glycemic and lipidemic markers and prevention of problems related to hypovitaminosis D.
- Conditions
- Healthy
- Being tested
- fortified bread, supplement, placebo
- Keywords
- vitamin D, fortified bread, efficacy, Vitamin D Deficiency
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fortified breadDietary supplement
Also called FB
50 g of fortified bread + placebo daily
supplementDietary supplement
Also called SP
vitamin D supplement+ plain bread
placeboDietary supplement
Also called PP
plain bread+placebo
| Study group | Role | What they receive |
|---|---|---|
| fortified bread | Experimental | daily intake of fortified bread (1000IU vitamin D per 50 g) plus placebo Receives: Dietary Supplement: fortified bread |
| supplement | Experimental | daily intake of plain bread (50 g) plus supplement (1000 IU per tablet) Receives: Dietary Supplement: supplement |
| placebo | Placebo comparator | daily intake of plain bread plus placebo Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
25-hydroxyvitamin D (nmol/L)
Measured: 8 weeks
Secondary outcomes (6)
serum glucose (mg/dL)
Measured: 8 weeks
serum triglyceride (mg/dL)
Measured: 8 weeks
serum total cholesterol (mg/dL)
Measured: 8 weeks
serum LDL
Measured: 8 weeks
serum HDL (mg/dL)
Measured: 8 weeks
serum PTH (pg/mL)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2015 (estimated)
- Study startJan 2015
- Primary completionMar 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Nutrition and Food Technology Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tirang R. Neyestani, Ph.D., National Nutrition and Food Technology Institute
- Investigators
- Tirang R. Neyestani, PhD, Study chair, Laboratory of Nutrition Research, National Nutrition and Food Technology Research Institute (NNFTRI) and Faculty of Nutrition Science and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02516254
- Sponsor's protocol ID
- 054-574
- Status last verified
- Feb 2019
- First submitted
- 3 Aug 2015
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Vitamin D-fortified Bread Versus Vitamin D Supplement in Healthy Adults: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02516254
- Acronym / sponsor ID
- 054-574
- Conditions
- Healthy
- Keywords
- vitamin D, fortified bread, efficacy, Vitamin D Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Nutrition and Food Technology InstituteUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 5 Aug 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.
The aim of this study is to evaluate the efficacy of daily intake of fortified bread with vitamin D on serum 25-hydroxyvitamin D level, glycemic and lipidemic status in healthy subjects compared to vitamin D supplement.
Detailed description
Sixty apparently healthy subjects will be selected. Participants who are receiving vitamin D, calcium or omega-3 supplements within the last three months will be excluded. Subjects will be assigned randomly to one of the three intervention groups: 1.fortified bread+placebo,2. plain bread+vitamin D supplements,3. plain bread+placebo. Each participant will consume 50 g of bread and supplement or placebo every day for 2 months.
At the first and last visits, dietary and laboratory assessments will be performed for all subjects. Primary outcomes are improvement in vitamin D status and secondary outcome is improvement of glycemic and lipidemic markers and prevention of problems related to hypovitaminosis D.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| fortified bread | Experimental | Dietary Supplement: fortified breaddaily intake of fortified bread (1000IU vitamin D per 50 g) plus placebo |
| supplement | Experimental | Dietary Supplement: supplementdaily intake of plain bread (50 g) plus supplement (1000 IU per tablet) |
| placebo | Placebo comparator | Dietary Supplement: placebodaily intake of plain bread plus placebo |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 20 to 50 years
- healthy subjects
- no receiving vitamin D or omega-3 supplement in past 3 months
Key exclusion criteria (1 listed)
- receiving vitamin D or omega-3 supplement during the study
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 |
|---|---|---|
| fortified breadAlso: FB50 g of fortified bread + placebo daily | Dietary supplement | fortified bread |
| supplementAlso: SPvitamin D supplement+ plain bread | Dietary supplement | supplement |
| placeboAlso: PPplain bread+placebo | Dietary supplement | placebo |
Primary outcome
25-hydroxyvitamin D (nmol/L)
Time frame: 8 weeks
6 secondary outcomes
serum glucose (mg/dL)
Time frame: 8 weeks
serum triglyceride (mg/dL)
Time frame: 8 weeks
serum total cholesterol (mg/dL)
Time frame: 8 weeks
serum LDL
Time frame: 8 weeks
serum HDL (mg/dL)
Time frame: 8 weeks
serum PTH (pg/mL)
Time frame: 8 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 27 Feb 2019.
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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.
Tirang R. Neyestani, PhD study chair
Laboratory of Nutrition Research, National Nutrition and Food Technology Research Institute (NNFTRI) and Faculty of Nutrition Science and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran
Questions about this trial
What is this clinical trial studying?
A study testing fortified bread and supplement in people with Healthy, run by National Nutrition and Food Technology Institute.
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 3 inclusion and 1 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 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
25-hydroxyvitamin D (nmol/L) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2019.