Zinc DeficiencyNCT00944853
Effects of Liquid Zinc Supplementation and Dispersible Zinc Tablets on Plasma Zinc Concentration
A study testing Liquid zinc syrup and Zinc tablet in people with Zinc Deficiency, run by University of California, Davis at 1 site in Burkina Faso.
Trial summary
The study aims to compare the effects of two different formulations of zinc supplements on plasma zinc concentrations among young Burkinabe children. Read more about this study
- Who is it for?
- Ages 6 to 23 monthsHealthy volunteers can take part
- Conditions the study is for
- Zinc Deficiency
- What is being tested?
- Liquid zinc syrup and Zinc tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 462 participants
- Where
- 1 siteBurkina Faso
- Study dates
- Aug 2009to Feb 2010
- 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 6 to 23 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- currently breast feeding
- informed consent of a parent or guardian.
Who cannot join
- symptomatic acute or chronic febrile infections
- diarrhea within the past week
- consuming vitamin or mineral supplements or zinc-fortified infant formulas
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Zinc Supplementation, Provided as Either a Liquid Zinc Solution or Dispersible Tablets, on Plasma Zinc Concentration Among Young Burkinabe Children
The study aims to compare the effects of two different formulations of zinc supplements on plasma zinc concentrations among young Burkinabe children.
Read the detailed description
- To investigate the effects of short-term zinc supplementation, provided either as a dispersible tablet containing zinc sulfate ("ZinCfant," Nutriset Ltd; Malaunay, France) or as a liquid ZnSO4 solution, on changes in serum zinc concentration, compared with a placebo in young Burkinabe children; and 2) to assess the relationship between change in serum zinc concentration and the presence of altered intestinal permeability within each treatment group.
- Conditions
- Zinc Deficiency
- Being tested
- Liquid zinc syrup, Zinc tablet, Liquid placebo supplement
- Keywords
- zinc supplement, prevention, zinc deficiency, plasma zinc concentration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid zinc syrupDietary supplement
Also called Phytofla, Banfora, Burkina Faso
Liquid zinc syrup containing 5 mg zinc as zinc sulfate
Zinc tabletDietary supplement
Also called Nutriset S.A.S., France
Dispersible zinc tablet containing 5 mg zinc
Liquid placebo supplementDietary supplement
Also called Phytofla, Banfora, Burkina Faso
Liquid placebo supplement containing 0 mg zinc
| Study group | Role | What they receive |
|---|---|---|
| Zinc syrup | Experimental | Liquid Zinc Syrup (ZnSO4) solution provided daily Receives: Dietary Supplement: Liquid zinc syrup |
| Zinc tablet | Experimental | Dispersible zinc tablets provided daily Receives: Dietary Supplement: Zinc tablet |
| Placebo | Placebo comparator | Liquid placebo supplement provided daily Receives: Dietary Supplement: Liquid placebo supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma zinc concentration
Measured: 3 weeks
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 completionDec 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 462 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Université Polytechnique de Bobo-Dioulasso, Helen Keller International, Nutriset
- Responsible party
- Sponsor
- Investigators
- Kenneth H Brown, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00944853
- Sponsor's protocol ID
- 200917272
- Other IDs
- ZincTab
- Status last verified
- Feb 2010
- First submitted
- 21 Jul 2009
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wessells KR, Ouedraogo ZP, Rouamba N, Hess SY, Ouedraogo JB, Brown KH. Short-term zinc supplementation with dispersible tablets or zinc sulfate solution yields similar positive effects on plasma zinc concentration of young children in Burkina Faso: a randomized controlled trial. J Pediatr. 2012 Jan;160(1):129-35.e3. doi: 10.1016/j.jpeds.2011.06.051. Epub 2011 Aug 25.
PubMed 21871635Wessells KR, Peerson JM, Brown KH. Within-individual differences in plasma ferritin, retinol-binding protein, and zinc concentrations in relation to inflammation observed during a short-term longitudinal study are similar to between-individual differences observed cross-sectionally. Am J Clin Nutr. 2019 May 1;109(5):1484-1492. doi: 10.1093/ajcn/nqz014.
PubMed 30976780Wessells KR, Hess SY, Ouedraogo ZP, Rouamba N, Ouedraogo JB, Brown KH. Asymptomatic malaria infection affects the interpretation of biomarkers of iron and vitamin A status, even after adjusting for systemic inflammation, but does not affect plasma zinc concentrations among young children in Burkina Faso. J Nutr. 2014 Dec;144(12):2050-8. doi: 10.3945/jn.114.200345. Epub 2014 Oct 1.
PubMed 25411038Wessells KR, Hess SY, Rouamba N, Ouedraogo ZP, Kellogg M, Goto R, Duggan C, Ouedraogo JB, Brown KH. Associations between intestinal mucosal function and changes in plasma zinc concentration following zinc supplementation. J Pediatr Gastroenterol Nutr. 2013 Sep;57(3):348-55. doi: 10.1097/MPG.0b013e31829b4e9e.
PubMed 23689263
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Zinc Supplementation, Provided as Either a Liquid Zinc Solution or Dispersible Tablets, on Plasma Zinc Concentration Among Young Burkinabe Children
- ClinicalTrials.gov ID
- NCT00944853
- Acronym / sponsor ID
- 200917272
- Conditions
- Zinc Deficiency
- Keywords
- zinc supplement, prevention, zinc deficiency, plasma zinc concentration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 462 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Université Polytechnique de Bobo-Dioulasso, Helen Keller International, Nutriset
- Study start
- Aug 2009
- Primary completion
- Dec 2009 (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 study aims to compare the effects of two different formulations of zinc supplements on plasma zinc concentrations among young Burkinabe children.
Detailed description
- To investigate the effects of short-term zinc supplementation, provided either as a dispersible tablet containing zinc sulfate ("ZinCfant," Nutriset Ltd; Malaunay, France) or as a liquid ZnSO4 solution, on changes in serum zinc concentration, compared with a placebo in young Burkinabe children; and 2) to assess the relationship between change in serum zinc concentration and the presence of altered intestinal permeability within each treatment group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Zinc syrup | Experimental | Dietary Supplement: Liquid zinc syrupLiquid Zinc Syrup (ZnSO4) solution provided daily |
| Zinc tablet | Experimental | Dietary Supplement: Zinc tabletDispersible zinc tablets provided daily |
| Placebo | Placebo comparator | Dietary Supplement: Liquid placebo supplementLiquid placebo supplement provided daily |
Who may qualify
- Ages
- 6 to 23 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- currently breast feeding
- informed consent of a parent or guardian.
Key exclusion criteria (3 listed)
- symptomatic acute or chronic febrile infections
- diarrhea within the past week
- consuming vitamin or mineral supplements or zinc-fortified infant formulas
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 |
|---|---|---|
| Liquid zinc syrupAlso: Phytofla, Banfora, Burkina FasoLiquid zinc syrup containing 5 mg zinc as zinc sulfate | Dietary supplement | Zinc syrup |
| Zinc tabletAlso: Nutriset S.A.S., FranceDispersible zinc tablet containing 5 mg zinc | Dietary supplement | Zinc tablet |
| Liquid placebo supplementAlso: Phytofla, Banfora, Burkina FasoLiquid placebo supplement containing 0 mg zinc | Dietary supplement | Placebo |
Primary outcome
Plasma zinc concentration
Time frame: 3 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 24 Feb 2017.
- Results publication: PubMed 21871635Wessells KR, Ouedraogo ZP, Rouamba N, Hess SY, Ouedraogo JB, Brown KH. Short-term zinc supplementation with dispersible tablets or zinc sulfate solution yields similar positive effects on plasma zinc concentration of young children in Burkina Faso: a randomized controlled trial. J Pediatr. 2012 Jan;160(1):129-35.e3. doi: 10.1016/j.jpeds.2011.06.051. Epub 2011 Aug 25.
- Derived from this study: PubMed 30976780Wessells KR, Peerson JM, Brown KH. Within-individual differences in plasma ferritin, retinol-binding protein, and zinc concentrations in relation to inflammation observed during a short-term longitudinal study are similar to between-individual differences observed cross-sectionally. Am J Clin Nutr. 2019 May 1;109(5):1484-1492. doi: 10.1093/ajcn/nqz014.
- Derived from this study: PubMed 25411038Wessells KR, Hess SY, Ouedraogo ZP, Rouamba N, Ouedraogo JB, Brown KH. Asymptomatic malaria infection affects the interpretation of biomarkers of iron and vitamin A status, even after adjusting for systemic inflammation, but does not affect plasma zinc concentrations among young children in Burkina Faso. J Nutr. 2014 Dec;144(12):2050-8. doi: 10.3945/jn.114.200345. Epub 2014 Oct 1.
- Derived from this study: PubMed 23689263Wessells KR, Hess SY, Rouamba N, Ouedraogo ZP, Kellogg M, Goto R, Duggan C, Ouedraogo JB, Brown KH. Associations between intestinal mucosal function and changes in plasma zinc concentration following zinc supplementation. J Pediatr Gastroenterol Nutr. 2013 Sep;57(3):348-55. doi: 10.1097/MPG.0b013e31829b4e9e.
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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 study testing Liquid zinc syrup and Zinc tablet in people with Zinc Deficiency, run by University of California, Davis at 1 site in Burkina Faso.
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 2 inclusion and 3 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 24 Feb 2017. 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 Burkina Faso. 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?
Plasma zinc concentration (time frame: 3 weeks). 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 NCT00944853, which also lists 4 linked publications.
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 24 Feb 2017.