Zinc DeficiencyNCT00944359
Impact of Preventive and Therapeutic Zinc Supplementation Programs Among Young Children
A study of Zinc Deficiency and Diarrhea, run by University of California, Davis at 1 site in Burkina Faso.
Trial summary
Zinc supplementation can either be provided in a lower daily dose to prevent zinc deficiency or in a higher dose for 10-14 days as part of the treatment of diarrhea. It is important to determine how best to integrate programs designed either to prevent zinc deficiency or to treat diarrhea. Read more about this study
- Who is it for?
- Ages 6 to 27 monthsHealthy volunteers can take part
- Conditions the study is for
- Zinc Deficiency, Diarrhea, Malaria
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7,680 participants
- Where
- 1 siteBurkina Faso
- Study dates
- Dec 2010to Feb 2012
- 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 27 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 6-27 months of age
- Plan to remain in study area for 1 year
Who cannot join
- Evidence of congenital abnormalities and chronic infection
- Severe anemia and severe acute malnutrition
- Consumption of micronutrient supplementation including zinc
Trial locations and contacts
1 site in 1 country.
Burkina Faso1 site
Institut de Recherche en Science de la Sante
Bobo-Dioulasso
About this study
Official title: Community-based Intervention Trial to Compare the Impact of Preventive and Therapeutic Zinc Supplementation Programs Among Young Children in Burkina Faso
Zinc supplementation can either be provided in a lower daily dose to prevent zinc deficiency or in a higher dose for 10-14 days as part of the treatment of diarrhea. It is important to determine how best to integrate programs designed either to prevent zinc deficiency or to treat diarrhea.
The overall objective of this project is to determine the most effective approach to prevent zinc deficiency and treat diarrhea, such that a single approach could provide the maximal beneficial impact on the health and nutritional status of young children and greatest simplicity of implementation.
Read the detailed description
This is a single-center cluster- and household-randomized, partially masked, community-based efficacy trial of zinc supplementation. The study sample consists of 5 study groups in one region, with 34 clusters randomly assigned to 3 types of intervention communities.
Communities will be randomly assigned to 1) early intervention communities, 2) later intervention communities, 3) non-intervention communities. Within each intervention cluster, children will be randomly assigned to the intervention group at the household level. Children aged 6-27 months at enrollment will be eligible. The study duration is 12 months.
The investigators will assess the relative impact of daily preventive zinc supplementation (7 mg zinc/d for one year), intermittent preventive supplementation (10 mg zinc/d for 10 days every three months for one year), and zinc treatment during episodes of diarrhea (20 mg zinc/d for 10 days beginning with each episode of diarrhea during one year). Outcomes that will be assessed include the incidence and duration of all episodes of diarrhea, the incidence of malaria, physical growth, and (in a sub-group) biochemical indicators of zinc, iron and vitamin A status.
- Conditions
- Zinc Deficiency, Diarrhea, Malaria
- Being tested
- Daily preventive Zn; placebo treatment, Therapeutic Zn; daily placebo, Intermittent Zn; placebo treatment, Surveillance control group
- Keywords
- zinc supplementation, diarrhea management, zinc deficiency, malaria
- Medical subject headings
- Diarrhea, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily preventive Zn; placebo treatmentDietary supplement
Also called Nutriset preventive zinc and therapeutic placebo supplement
7 mg zinc / day and placebo supplement during diarrhea episodes
Therapeutic Zn; daily placeboDietary supplement
Also called Nutriset ZinCfant
20 mg zinc / day for 10 days during diarrhea episodes and daily placebo supplement
Intermittent Zn; placebo treatmentDietary supplement
Also called Nutriset zinc supplement
10 mg zinc for 10 days every 3 months, placebo supplements daily for all other days during 12 months; placebo supplements during diarrhea episodes
Surveillance control groupOther
Active weekly morbidity surveillance for 3 months. New surveillance control group will be randomly assigned to intervention groups every 3 months
| Study group | Role | What they receive |
|---|---|---|
| Daily preventive Zn; placebo treatment | Experimental | 7 mg zinc per day for 12 months and placebo supplement during diarrhea episode Receives: Dietary Supplement: Daily preventive Zn; placebo treatment |
| Therapeutic Zn; daily placebo | Experimental | 20 mg of zinc for 10 days during episodes of diarrhea and daily placebo supplement Receives: Dietary Supplement: Therapeutic Zn; daily placebo |
| Intermittent Zn; placebo treatment | Experimental | 10 mg zinc for 10 days every 3 months, daily placebo during 80 days of 3 months period and placebo during diarrhea episode Receives: Dietary Supplement: Intermittent Zn; placebo treatment |
| Surveillance control group | Active comparator | Surveillance control group will be randomly assigned to intervention groups every 3 months Receives: Other: Surveillance control group |
| Non-intervention | No intervention | Standard care provided by health system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in length and length-for-age Z-score
Measured: 12 months
Change in weight and weight-for-age
Measured: 12 months
Incidence of diarrhea and laboratory-confirmed malaria
Measured: 12 months
Change in plasma zinc concentration
Measured: 12 months
Secondary outcomes (2)
Incidence of stunting, underweight, and wasting
Measured: 12 months
Change in hemoglobin and iron status
Measured: 12 months
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 startDec 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 7,680 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, Thrasher Research Fund, Canadian International Development Agency
- Responsible party
- Sponsor
- Investigators
- Kenneth H Brown, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00944359
- Sponsor's protocol ID
- 222218
- Other IDs
- Zinc 7-20
- Status last verified
- Jul 2018
- First submitted
- 21 Jul 2009
- Last updated
- 13 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Becquey E, Ouedraogo CT, Hess SY, Rouamba N, Prince L, Ouedraogo JB, Vosti SA, Brown KH. Comparison of Preventive and Therapeutic Zinc Supplementation in Young Children in Burkina Faso: A Cluster-Randomized, Community-Based Trial. J Nutr. 2016 Oct;146(10):2058-2066. doi: 10.3945/jn.116.230128. Epub 2016 Aug 3.
PubMed 27489011Hess SY, Peerson JM, Becquey E, Abbeddou S, Ouedraogo CT, Some JW, Yakes Jimenez E, Ouedraogo JB, Vosti SA, Rouamba N, Brown KH. Differing growth responses to nutritional supplements in neighboring health districts of Burkina Faso are likely due to benefits of small-quantity lipid-based nutrient supplements (LNS). PLoS One. 2017 Aug 3;12(8):e0181770. doi: 10.1371/journal.pone.0181770. eCollection 2017.
PubMed 28771493Imdad A, Rogner J, Sherwani RN, Sidhu J, Regan A, Haykal MR, Tsistinas O, Smith A, Chan XHS, Mayo-Wilson E, Bhutta ZA. Zinc supplementation for preventing mortality, morbidity, and growth failure in children aged 6 months to 12 years. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD009384. doi: 10.1002/14651858.CD009384.pub3.
PubMed 36994923
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-based Intervention Trial to Compare the Impact of Preventive and Therapeutic Zinc Supplementation Programs Among Young Children in Burkina Faso
- ClinicalTrials.gov ID
- NCT00944359
- Acronym / sponsor ID
- 222218
- Conditions
- Zinc Deficiency, Diarrhea, Malaria
- Keywords
- zinc supplementation, diarrhea management, zinc deficiency, malaria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,680 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Université Polytechnique de Bobo-Dioulasso, Helen Keller International, Thrasher Research Fund, Canadian International Development Agency
- Study start
- Dec 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (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.
Zinc supplementation can either be provided in a lower daily dose to prevent zinc deficiency or in a higher dose for 10-14 days as part of the treatment of diarrhea. It is important to determine how best to integrate programs designed either to prevent zinc deficiency or to treat diarrhea.
The overall objective of this project is to determine the most effective approach to prevent zinc deficiency and treat diarrhea, such that a single approach could provide the maximal beneficial impact on the health and nutritional status of young children and greatest simplicity of implementation.
Detailed description
This is a single-center cluster- and household-randomized, partially masked, community-based efficacy trial of zinc supplementation. The study sample consists of 5 study groups in one region, with 34 clusters randomly assigned to 3 types of intervention communities.
Communities will be randomly assigned to 1) early intervention communities, 2) later intervention communities, 3) non-intervention communities. Within each intervention cluster, children will be randomly assigned to the intervention group at the household level. Children aged 6-27 months at enrollment will be eligible. The study duration is 12 months.
The investigators will assess the relative impact of daily preventive zinc supplementation (7 mg zinc/d for one year), intermittent preventive supplementation (10 mg zinc/d for 10 days every three months for one year), and zinc treatment during episodes of diarrhea (20 mg zinc/d for 10 days beginning with each episode of diarrhea during one year). Outcomes that will be assessed include the incidence and duration of all episodes of diarrhea, the incidence of malaria, physical growth, and (in a sub-group) biochemical indicators of zinc, iron and vitamin A status.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Daily preventive Zn; placebo treatment | Experimental | Dietary Supplement: Daily preventive Zn; placebo treatment7 mg zinc per day for 12 months and placebo supplement during diarrhea episode |
| Therapeutic Zn; daily placebo | Experimental | Dietary Supplement: Therapeutic Zn; daily placebo20 mg of zinc for 10 days during episodes of diarrhea and daily placebo supplement |
| Intermittent Zn; placebo treatment | Experimental | Dietary Supplement: Intermittent Zn; placebo treatment10 mg zinc for 10 days every 3 months, daily placebo during 80 days of 3 months period and placebo during diarrhea episode |
| Surveillance control group | Active comparator | Other: Surveillance control groupSurveillance control group will be randomly assigned to intervention groups every 3 months |
| Non-intervention | No intervention | –Standard care provided by health system |
Who may qualify
- Ages
- 6 to 27 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 6-27 months of age
- Plan to remain in study area for 1 year
Key exclusion criteria (3 listed)
- Evidence of congenital abnormalities and chronic infection
- Severe anemia and severe acute malnutrition
- Consumption of micronutrient supplementation including zinc
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 |
|---|---|---|
| Daily preventive Zn; placebo treatmentAlso: Nutriset preventive zinc and therapeutic placebo supplement7 mg zinc / day and placebo supplement during diarrhea episodes | Dietary supplement | Daily preventive Zn; placebo treatment |
| Therapeutic Zn; daily placeboAlso: Nutriset ZinCfant20 mg zinc / day for 10 days during diarrhea episodes and daily placebo supplement | Dietary supplement | Therapeutic Zn; daily placebo |
| Intermittent Zn; placebo treatmentAlso: Nutriset zinc supplement10 mg zinc for 10 days every 3 months, placebo supplements daily for all other days during 12 months; placebo supplements during diarrhea episodes | Dietary supplement | Intermittent Zn; placebo treatment |
| Surveillance control groupActive weekly morbidity surveillance for 3 months. New surveillance control group will be randomly assigned to intervention groups every 3 months | Other | Surveillance control group |
Primary outcome
Change in length and length-for-age Z-score
Time frame: 12 months
Change in weight and weight-for-age
Time frame: 12 months
Incidence of diarrhea and laboratory-confirmed malaria
Time frame: 12 months
Change in plasma zinc concentration
Time frame: 12 months
2 secondary outcomes
Incidence of stunting, underweight, and wasting
Time frame: 12 months
Change in hemoglobin and iron status
Time frame: 12 months
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 13 Jul 2018.
- Results publication: PubMed 27489011Becquey E, Ouedraogo CT, Hess SY, Rouamba N, Prince L, Ouedraogo JB, Vosti SA, Brown KH. Comparison of Preventive and Therapeutic Zinc Supplementation in Young Children in Burkina Faso: A Cluster-Randomized, Community-Based Trial. J Nutr. 2016 Oct;146(10):2058-2066. doi: 10.3945/jn.116.230128. Epub 2016 Aug 3.
- Results publication: PubMed 28771493Hess SY, Peerson JM, Becquey E, Abbeddou S, Ouedraogo CT, Some JW, Yakes Jimenez E, Ouedraogo JB, Vosti SA, Rouamba N, Brown KH. Differing growth responses to nutritional supplements in neighboring health districts of Burkina Faso are likely due to benefits of small-quantity lipid-based nutrient supplements (LNS). PLoS One. 2017 Aug 3;12(8):e0181770. doi: 10.1371/journal.pone.0181770. eCollection 2017.
- Derived from this study: PubMed 36994923Imdad A, Rogner J, Sherwani RN, Sidhu J, Regan A, Haykal MR, Tsistinas O, Smith A, Chan XHS, Mayo-Wilson E, Bhutta ZA. Zinc supplementation for preventing mortality, morbidity, and growth failure in children aged 6 months to 12 years. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD009384. doi: 10.1002/14651858.CD009384.pub3.
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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 of Zinc Deficiency and Diarrhea, 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 13 Jul 2018. 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. 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 length and length-for-age Z-score (time frame: 12 months). The study lists 4 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 NCT00944359, which also lists 3 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 13 Jul 2018.