Zinc DeficiencyPhase 4NCT00944723
Impact of Mass Zinc Fortification Programs on Plasma Zinc Concentration
A Phase 4 study testing Zinc-fortified bread, Zinc supplement and Non-fortified bread in people with Zinc Deficiency, run by University of California, Davis at 1 site in Senegal.
Trial summary
The purpose of the study is to evaluate the use of plasma zinc concentration for assessing the impact of mass zinc fortification programs. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Zinc Deficiency
- What is being tested?
- Zinc-fortified bread, Zinc supplement and Non-fortified bread
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteSenegal
- Study dates
- Aug 2009to Feb 2010
- Phase
- Phase 4
- 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 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- apparently healthy males
Who cannot join
- Hemoglobin <80 g/L
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Use of Plasma Zinc Concentration for Assessing the Impact of Targeted and Mass Zinc Fortification Programs
The purpose of the study is to evaluate the use of plasma zinc concentration for assessing the impact of mass zinc fortification programs.
Read the detailed description
The objectives of the present study are to determine whether plasma zinc concentration changes in response to additional zinc consumption, as provided by zinc-fortified cereal-based complementary foods fed to adult men (fortified at a level consistent with currently proposed levels). The following specific steps will be completed:
- Zinc-fortified breads prepared from zinc-fortified wheat flour will be developed with assistance from experts in food technology.
- A four-week feeding trial will be implemented to assess the change in plasma zinc concentration among young adult men who receive: a) bread fortified with a moderate amount of zinc and a liquid vitamin preparation between meals; b) bread fortified with a large amount zinc and a liquid vitamin preparation between meals; c) non-zinc-fortified bread and a liquid vitamin preparation between meals [negative control group]; and d) non-zinc-fortified bread and a zinc-containing liquid vitamin preparation between meals [positive control group].
- Conditions
- Zinc Deficiency
- Being tested
- Zinc-fortified bread, Zinc supplement, Non-fortified bread, Placebo supplement
- Keywords
- zinc fortification, zinc supplementation, plasma zinc concentration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc-fortified breadDietary supplement
Also called Les Grands Moulins de Dakar
Bread made with zinc-fortified wheat flour
Zinc supplementDietary supplement
Also called Zinc sulfate and B vitamins, DSM
Liquid supplement with zinc
Non-fortified breadDietary supplement
Also called Les Grands Moulins de Dakar
Daily consumption of non-fortified bread
Placebo supplementDietary supplement
Also called B-vitamins, DSM
Daily intake of placebo supplement
| Study group | Role | What they receive |
|---|---|---|
| Zinc-fortified bread (10 mg zinc/d) | Experimental | Daily consumption of zinc fortified bread for 1 month Receives: Dietary Supplement: Zinc-fortified bread; Dietary Supplement: Placebo supplement |
| Zinc fortified bread (20 mg zinc/d) | Experimental | Daily consumption of zinc fortified bread for 1 month. Receives: Dietary Supplement: Zinc-fortified bread; Dietary Supplement: Placebo supplement |
| Zinc supplemented group | Experimental | Daily consumption of non-fortified bread and daily intake of zinc supplement (10 mg zinc/d) Receives: Dietary Supplement: Zinc supplement; Dietary Supplement: Non-fortified bread |
| Non-fortified group | Placebo comparator | Daily consumption of non-fortified bread and a placebo supplement for 1 month. Receives: Dietary Supplement: Non-fortified bread; Dietary Supplement: Placebo supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma zinc concentration
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2009 (estimated)
- Study startAug 2009
- Primary completionJan 2010
- Study completionFeb 2010
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 Zinc DeficiencyStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Helen Keller International, Cheikh Anta Diop University, Senegal, Global Alliance for Improved Nutrition
- Investigators
- Kenneth H Brown, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00944723
- Sponsor's protocol ID
- 107008-2
- Other IDs
- 200816610
- Status last verified
- Feb 2010
- First submitted
- 21 Jul 2009
- Last updated
- 19 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Aaron GJ, Ba Lo N, Hess SY, Guiro AT, Wade S, Brown KH. Plasma zinc concentration increases within 2 weeks in healthy Senegalese men given liquid supplemental zinc, but not zinc-fortified wheat bread. J Nutr. 2011 Jul;141(7):1369-74. doi: 10.3945/jn.110.136952. Epub 2011 May 11.
PubMed 21562238
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Use of Plasma Zinc Concentration for Assessing the Impact of Targeted and Mass Zinc Fortification Programs
- ClinicalTrials.gov ID
- NCT00944723
- Acronym / sponsor ID
- 107008-2
- Conditions
- Zinc Deficiency
- Keywords
- zinc fortification, zinc supplementation, plasma zinc concentration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Helen Keller International, Cheikh Anta Diop University, Senegal, Global Alliance for Improved Nutrition
- Study start
- Aug 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 23 Jul 2009 (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 purpose of the study is to evaluate the use of plasma zinc concentration for assessing the impact of mass zinc fortification programs.
Detailed description
The objectives of the present study are to determine whether plasma zinc concentration changes in response to additional zinc consumption, as provided by zinc-fortified cereal-based complementary foods fed to adult men (fortified at a level consistent with currently proposed levels). The following specific steps will be completed:
- Zinc-fortified breads prepared from zinc-fortified wheat flour will be developed with assistance from experts in food technology.
- A four-week feeding trial will be implemented to assess the change in plasma zinc concentration among young adult men who receive: a) bread fortified with a moderate amount of zinc and a liquid vitamin preparation between meals; b) bread fortified with a large amount zinc and a liquid vitamin preparation between meals; c) non-zinc-fortified bread and a liquid vitamin preparation between meals [negative control group]; and d) non-zinc-fortified bread and a zinc-containing liquid vitamin preparation between meals [positive control group].
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Zinc-fortified bread (10 mg zinc/d) | Experimental | Dietary Supplement: Zinc-fortified bread, Dietary Supplement: Placebo supplementDaily consumption of zinc fortified bread for 1 month |
| Zinc fortified bread (20 mg zinc/d) | Experimental | Dietary Supplement: Zinc-fortified bread, Dietary Supplement: Placebo supplementDaily consumption of zinc fortified bread for 1 month. |
| Zinc supplemented group | Experimental | Dietary Supplement: Zinc supplement, Dietary Supplement: Non-fortified breadDaily consumption of non-fortified bread and daily intake of zinc supplement (10 mg zinc/d) |
| Non-fortified group | Placebo comparator | Dietary Supplement: Non-fortified bread, Dietary Supplement: Placebo supplementDaily consumption of non-fortified bread and a placebo supplement for 1 month. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- apparently healthy males
Key exclusion criteria (1 listed)
- Hemoglobin <80 g/L
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 |
|---|---|---|
| Zinc-fortified breadAlso: Les Grands Moulins de DakarBread made with zinc-fortified wheat flour | Dietary supplement | Zinc fortified bread (20 mg zinc/d), Zinc-fortified bread (10 mg zinc/d) |
| Zinc supplementAlso: Zinc sulfate and B vitamins, DSMLiquid supplement with zinc | Dietary supplement | Zinc supplemented group |
| Non-fortified breadAlso: Les Grands Moulins de DakarDaily consumption of non-fortified bread | Dietary supplement | Non-fortified group, Zinc supplemented group |
| Placebo supplementAlso: B-vitamins, DSMDaily intake of placebo supplement | Dietary supplement | Non-fortified group, Zinc fortified bread (20 mg zinc/d), Zinc-fortified bread (10 mg zinc/d) |
Primary outcome
Plasma zinc concentration
Time frame: 1 month
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 19 Feb 2010.
- Derived from this study: PubMed 21562238Aaron GJ, Ba Lo N, Hess SY, Guiro AT, Wade S, Brown KH. Plasma zinc concentration increases within 2 weeks in healthy Senegalese men given liquid supplemental zinc, but not zinc-fortified wheat bread. J Nutr. 2011 Jul;141(7):1369-74. doi: 10.3945/jn.110.136952. Epub 2011 May 11.
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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.
Kenneth H Brown, MD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zinc-fortified bread, Zinc supplement and Non-fortified bread in people with Zinc Deficiency, run by University of California, Davis at 1 site in Senegal.
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 1 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 19 Feb 2010. 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 Senegal. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Plasma zinc concentration (time frame: 1 month). 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 NCT00944723, 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 19 Feb 2010.