Effects of; SerumPhase 2/3NCT04574544
Zinc Supplementation and Nutrition Education Among Children in the Rural Community
A Phase 2/3 study testing Zinc Supplementation and Nutrition education of mothers in people with Effects of; Serum, run by University of Douala.
Trial summary
Malnutrition among children, especially stunting is a public health problem in Cameroon. This study assesses the impact of zinc supplementation of children and nutrition education of mothers on the nutritional status of the children in the rural community. Read more about this study
- Who is it for?
- Ages 6 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Effects of; Serum
- What is being tested?
- Zinc Supplementation and Nutrition education of mothers
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2015to 30 Dec 2015
- Phase
- Phase 2/3
- 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 59 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- To have an age between 6 to 59 months
- To have signature of informed consent by the parents
Who cannot join
- To be illnes
- To have severe malnutrition
About this study
Official title: Pilot Zinc Supplementation and Nutrition Education Among Children in the Rural Community, Cameroon
Malnutrition among children, especially stunting is a public health problem in Cameroon. This study assesses the impact of zinc supplementation of children and nutrition education of mothers on the nutritional status of the children in the rural community. Dietary surveys, nutritional status, zinc supplementation of children and nutrition education of mothers were carried out. After nutrition education and zinc supplementation, the study showed positive impact of both intervention on the nutritional status of children.
Read the detailed description
A questionnaire was developed, tested and adjusted prior the field survey. During the study, the knowledge of mothers on child nutrition, the eating habits of children, the estimated consumption of energy, nutrients of children and food availability on the market during harvesting and sowing seasons were evaluated. Moreover, data on zinc supplementation and nutrition education sessions conducted with mothers of these children were collected. The impact of zinc supplementation and maternal education was evaluated by measuring height/age, weight/age and weight/height indices, and levels of serum albumin, calcium, zinc, iron, magnesium and phosphorus before and after interventions.
- Conditions
- Effects of; Serum
- Being tested
- Zinc Supplementation, Nutrition education of mothers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc SupplementationDrug
Also called Supplementation
The 25 supplemented children had received an oral zinc supplement per day for 14 days and had no dietary restrictions.
Nutrition education of mothersBehavioural
Also called Maternal education
Nutritional information was delivered to each mother to facilitate a change in bad eating habits observed, improve knowledge, attitudes and skills of mothers on child nutrition. The anthropometric and biochemistry parameters of children were taken before and after the maternal nutrition education
| Study group | Role | What they receive |
|---|---|---|
| Zinc supplementation | Experimental | The 25 supplemented children had received an oral dose of 10 mg of zinc sulphate per day for 14 days Receives: Drug: Zinc Supplementation |
| Nutrition education of mothers | Experimental | Nutritional information was delivered to each mother to facilitate a change in bad eating habits observed, improve knowledge, attitudes and skills of mothers on child nutrition. The anthropometric and biochemistry parameters of children were taken before and after the maternal nutrition education Receives: Behavioral: Nutrition education of mothers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Zinc supplementation among children in the rural community
The supplemented children received the oral zinc sulphate per day for two week and serum zinc concentration were taken before and after the intervention.
Measured: Zinc supplementation: 14 days
Nutrition education of mothers and improvement of nutritionnal status of children
The appropriate information of child nutrition was delivered to each mother. Before and after that maternal nutrition education, the anthropometric and biochemistry parameters of children were mesured.
Measured: Impact of maternal education: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start1 Mar 2015
- Primary completion15 Dec 2015
- Study completion30 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effects of; SerumStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Evaluation of the anthropometric and biochemistry parameters of children before and after an intervention.
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Douala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NOLLA Nicolas Policarpe, University of Douala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04574544
- Sponsor's protocol ID
- UDouala
- Status last verified
- Sep 2020
- First submitted
- 15 Sep 2020
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To share the data with other researchers, we want to publish our study to international review.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Zinc Supplementation and Nutrition Education Among Children in the Rural Community, Cameroon
- ClinicalTrials.gov ID
- NCT04574544
- Acronym / sponsor ID
- UDouala
- Conditions
- Effects of; Serum
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of DoualaUniversity, hospital or other
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 15 Dec 2015 (actual)
- Study completion
- 30 Dec 2015 (actual)
- First posted
- 5 Oct 2020 (actual)
- 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.
Malnutrition among children, especially stunting is a public health problem in Cameroon. This study assesses the impact of zinc supplementation of children and nutrition education of mothers on the nutritional status of the children in the rural community. Dietary surveys, nutritional status, zinc supplementation of children and nutrition education of mothers were carried out. After nutrition education and zinc supplementation, the study showed positive impact of both intervention on the nutritional status of children.
Detailed description
A questionnaire was developed, tested and adjusted prior the field survey. During the study, the knowledge of mothers on child nutrition, the eating habits of children, the estimated consumption of energy, nutrients of children and food availability on the market during harvesting and sowing seasons were evaluated. Moreover, data on zinc supplementation and nutrition education sessions conducted with mothers of these children were collected. The impact of zinc supplementation and maternal education was evaluated by measuring height/age, weight/age and weight/height indices, and levels of serum albumin, calcium, zinc, iron, magnesium and phosphorus before and after interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Evaluation of the anthropometric and biochemistry parameters of children before and after an intervention.
| Arm | Type | Receives |
|---|---|---|
| Zinc supplementation | Experimental | Drug: Zinc SupplementationThe 25 supplemented children had received an oral dose of 10 mg of zinc sulphate per day for 14 days |
| Nutrition education of mothers | Experimental | Behavioral: Nutrition education of mothersNutritional information was delivered to each mother to facilitate a change in bad eating habits observed, improve knowledge, attitudes and skills of mothers on child nutrition. The anthropometric and biochemistry parameters of children were taken before and after the maternal nutrition education |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- To have an age between 6 to 59 months
- To have signature of informed consent by the parents
Key exclusion criteria (2 listed)
- To be illnes
- To have severe malnutrition
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 SupplementationAlso: SupplementationThe 25 supplemented children had received an oral zinc supplement per day for 14 days and had no dietary restrictions. | Drug | Zinc supplementation |
| Nutrition education of mothersAlso: Maternal educationNutritional information was delivered to each mother to facilitate a change in bad eating habits observed, improve knowledge, attitudes and skills of mothers on child nutrition. The anthropometric and biochemistry parameters of children were taken before and after the maternal nutrition education | Behavioural | Nutrition education of mothers |
Primary outcome
Zinc supplementation among children in the rural community
Time frame: Zinc supplementation: 14 days
The supplemented children received the oral zinc sulphate per day for two week and serum zinc concentration were taken before and after the intervention.
Nutrition education of mothers and improvement of nutritionnal status of children
Time frame: Impact of maternal education: 10 months
The appropriate information of child nutrition was delivered to each mother. Before and after that maternal nutrition education, the anthropometric and biochemistry parameters of children were mesured.
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 6 Oct 2020.
- Individual participant dataSharing planned: No. To share the data with other researchers, we want to publish our study to international review.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Zinc Supplementation and Nutrition education of mothers in people with Effects of; Serum, run by University of Douala.
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 2 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 6 Oct 2020. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Zinc supplementation among children in the rural community (time frame: Zinc supplementation: 14 days). 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?
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 6 Oct 2020.