Nutrient DeficiencyNCT04669106
Mineral and Enzyme Deficiency Diseases Associated With Nutritional Diseases in Society
An observational study of Nutrient Deficiency, run by Universitas Sumatera Utara at 1 site in Indonesia.
Trial summary
Nutritional deficiency disease is a disease caused by nutritional deficiencies, including macronutrients and micronutrients. Macronutrient diseases are diseases caused by deficiency of protein, fat and carbohydrates. This deficiency will usually show clinical symptoms that directly affect nutritional status. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Nutrient Deficiency
- What is being tested?
- laboratory clinical trial study
- How many people
- 180 participants
- Where
- 1 siteIndonesia
- Study dates
- 2 Sep 2020to 10 Nov 2020
- Phase
- Observational
- 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 40 years
- Women only
- Adult
Study population: The number of research subjects to be taken was 180 subjects with 90 research subjects coming from mothers who had healthy children and 90 research subjects came from mothers who had stunted children or other nutritional disorders. The research stage will run after going through the inclusion of research subjects, namely mothers who have healthy children and mothers who have nutritionally deficient children, aged 20-40 years.
Who may be able to join
- mothers who had healthy children
Who cannot join
- mothers who have healthy children and mothers who have nutritionally deficient children
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Faculty of Medicine Universitas Sumatera Utara
Medan, North Sumatra, 20155
About this study
Nutritional deficiency disease is a disease caused by nutritional deficiencies, including macronutrients and micronutrients. Macronutrient diseases are diseases caused by deficiency of protein, fat and carbohydrates. This deficiency will usually show clinical symptoms that directly affect nutritional status. This study aims to study and examine mineral intake, dietary patterns of research subjects, mineral and enzyme levels, and soil condition data. The number of research subjects to be taken was 180 subjects with 90 research subjects coming from mothers who had healthy children and 90 research subjects came from mothers who had stunted children or other nutritional disorders. The research stage will run after going through the inclusion of research subjects, namely mothers who have healthy children and mothers who have nutritionally deficient children, aged 20-40 years. The research stage consisted of two stages. The statistical analysis used is to use the ANOVA test, which will then compile a manuscript.
Read the detailed description
This study aims to study and examine mineral intake, dietary patterns of research subjects, mineral and enzyme levels, and soil condition data. The number of research subjects to be taken was 180 subjects with 90 research subjects coming from mothers who had healthy children and 90 research subjects came from mothers who had stunted children or other nutritional disorders. The research stage will run after going through the inclusion of research subjects, namely mothers who have healthy children and mothers who have nutritionally deficient children, aged 20-40 years. The research stage consisted of two stages. The statistical analysis used is to use the ANOVA test, which will then compile a manuscript.
This research is a case control study, with primary data collection, is a laboratory clinical trial study on the subject of mothers who have children aged 2-3 years, aged 20-40 years. The number of research subjects to be taken was 180 subjects with 90 research subjects coming from mothers who had healthy children and 90 research subjects came from mothers who had stunted children or other nutritional disorders.
The research stage consisted of two stages, the first stage was the initial screening of the primary data of the research subjects, namely by analyzing food intake including mineral intake data, the diet of the research subjects, mineral and enzyme levels, and data on soil conditions in the area. The second stage was to analyze the relationship between the existing variables so that the most significant relationship was seen between the differences in diet, mineral content, enzyme levels, and soil content between the two groups. The statistical analysis used was to use the ANOVA test.
- Conditions
- Nutrient Deficiency
- Being tested
- laboratory clinical trial study
- Keywords
- nutritional deficiency, macronutrient, mineral, enzyme, stunting
- Medical subject headings
- Malnutrition, Calcinosis, Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory clinical trial studyOther
The research stage consisted of two stages, the first stage was the initial screening of the primary data of the research subjects, namely by analyzing food intake including mineral intake data, the diet of the research subjects, mineral and enzyme levels, and data on soil conditions in the area. The second stage was to analyze the relationship between the existing variables so that the most significant relationship was seen between the differences in diet, mineral content, enzyme levels, and soil content between the two groups.
| Study group | Role | What they receive |
|---|---|---|
| Healthy group | 90 research subjects coming from mothers who had healthy children Receives: Other: laboratory clinical trial study | |
| Stunting group | 90 research subjects came from mothers who had stunted children or other nutritional disorders Receives: Other: laboratory clinical trial study |
What is being measured
The primary outcome is the main question the study is designed to answer.
calsium, vitamin D, zinc and ferrum serum level
calsium, vitamin D, zinc and ferrum serum level in the mother's blood
Measured: up to 1 day
lipase and amylase enzime pacreatic serum level
lipase and amylase enzime pacreatic serum level in the mother's blood
Measured: up to 1 day
dietary intake per day
dietary intake per day of mother and child
Measured: up to 2 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start2 Sep 2020
- Primary completion8 Oct 2020
- Study completion10 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrient DeficiencyStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Sumatera Utara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DINA KEUMALA SARI, Universitas Sumatera Utara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04669106
- Sponsor's protocol ID
- USumateraUtara 3
- Status last verified
- Dec 2020
- First submitted
- 26 Nov 2020
- Last updated
- 16 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mineral and Enzyme Deficiency Diseases Associated With Nutritional Diseases in Society
- ClinicalTrials.gov ID
- NCT04669106
- Acronym / sponsor ID
- USumateraUtara 3
- Conditions
- Nutrient Deficiency
- Keywords
- nutritional deficiency, macronutrient, mineral, enzyme, stunting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Universitas Sumatera UtaraUniversity, hospital or other
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 8 Oct 2020 (actual)
- Study completion
- 10 Nov 2020 (actual)
- First posted
- 16 Dec 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.
Nutritional deficiency disease is a disease caused by nutritional deficiencies, including macronutrients and micronutrients. Macronutrient diseases are diseases caused by deficiency of protein, fat and carbohydrates. This deficiency will usually show clinical symptoms that directly affect nutritional status. This study aims to study and examine mineral intake, dietary patterns of research subjects, mineral and enzyme levels, and soil condition data. The number of research subjects to be taken was 180 subjects with 90 research subjects coming from mothers who had healthy children and 90 research subjects came from mothers who had stunted children or other nutritional disorders. The research stage will run after going through the inclusion of research subjects, namely mothers who have healthy children and mothers who have nutritionally deficient children, aged 20-40 years. The research stage consisted of two stages. The statistical analysis used is to use the ANOVA test, which will then compile a manuscript.
Detailed description
This study aims to study and examine mineral intake, dietary patterns of research subjects, mineral and enzyme levels, and soil condition data. The number of research subjects to be taken was 180 subjects with 90 research subjects coming from mothers who had healthy children and 90 research subjects came from mothers who had stunted children or other nutritional disorders. The research stage will run after going through the inclusion of research subjects, namely mothers who have healthy children and mothers who have nutritionally deficient children, aged 20-40 years. The research stage consisted of two stages. The statistical analysis used is to use the ANOVA test, which will then compile a manuscript.
This research is a case control study, with primary data collection, is a laboratory clinical trial study on the subject of mothers who have children aged 2-3 years, aged 20-40 years. The number of research subjects to be taken was 180 subjects with 90 research subjects coming from mothers who had healthy children and 90 research subjects came from mothers who had stunted children or other nutritional disorders.
The research stage consisted of two stages, the first stage was the initial screening of the primary data of the research subjects, namely by analyzing food intake including mineral intake data, the diet of the research subjects, mineral and enzyme levels, and data on soil conditions in the area. The second stage was to analyze the relationship between the existing variables so that the most significant relationship was seen between the differences in diet, mineral content, enzyme levels, and soil content between the two groups. The statistical analysis used was to use the ANOVA test.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy group | – | Other: laboratory clinical trial study90 research subjects coming from mothers who had healthy children |
| Stunting group | – | Other: laboratory clinical trial study90 research subjects came from mothers who had stunted children or other nutritional disorders |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- The number of research subjects to be taken was 180 subjects with 90 research subjects coming from mothers who had healthy children and 90 research subjects came from mothers who had stunted children or other nutritional disorders. The research stage will run after going through the inclusion of research subjects, namely mothers who have healthy children and mothers who have nutritionally deficient children, aged 20-40 years.
Key inclusion criteria (1 listed)
- mothers who had healthy children
Key exclusion criteria (1 listed)
- mothers who have healthy children and mothers who have nutritionally deficient children
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 |
|---|---|---|
| laboratory clinical trial studyThe research stage consisted of two stages, the first stage was the initial screening of the primary data of the research subjects, namely by analyzing food intake including mineral intake data, the diet of the research subjects, mineral and enzyme levels, and data on soil conditions in the area. The second stage was to analyze the relationship between the existing variables so that the most significant relationship was seen between the differences in diet, mineral content, enzyme levels, and soil content between the two groups. | Other | Healthy group, Stunting group |
Primary outcome
calsium, vitamin D, zinc and ferrum serum level
Time frame: up to 1 day
calsium, vitamin D, zinc and ferrum serum level in the mother's blood
lipase and amylase enzime pacreatic serum level
Time frame: up to 1 day
lipase and amylase enzime pacreatic serum level in the mother's blood
dietary intake per day
Time frame: up to 2 day
dietary intake per day of mother and child
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 16 Dec 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutrient Deficiency, run by Universitas Sumatera Utara at 1 site in Indonesia.
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 16 Dec 2020. 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 Indonesia. 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?
calsium, vitamin D, zinc and ferrum serum level (time frame: up to 1 day). The study lists 3 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 16 Dec 2020.