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CompletedNCT04669106Updated Dec 16, 2020

Mineral and Enzyme Deficiency Diseases Associated With Nutritional Diseases in Society

An observational study in Nutrient Deficiency, sponsored by Universitas Sumatera Utara. Completed at 1 site in Indonesia. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2020-12-16.

Sponsored by Universitas Sumatera Utara · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
180
Ages
20 Years to 40 Years
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Nutrient Deficiency

Keywords

  • nutritional deficiency
  • macronutrient
  • mineral
  • enzyme
  • stunting
03

In context

Deficiency Diseases

159 studies on the registry are indexed under Deficiency Diseases; 15 are open to participants now.

This study's enrollment of 180 is above the median of 140 across 29 observational studies indexed under Deficiency Diseases.

Browse Deficiency Diseases studies →

Lead sponsor

Universitas Sumatera Utara is the lead sponsor of 23 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Female
Sampling method
Non-probability sample

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.

Inclusion criteria

  • mothers who had healthy children

Exclusion criteria

Exclusion Criteria:

  • mothers who have healthy children and mothers who have nutritionally deficient children
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
180 participants (actual)
Patient registry
No

Groups and cohorts

  • Healthy group

    90 research subjects coming from mothers who had healthy children

    Other: laboratory clinical trial study

  • Stunting group

    90 research subjects came from mothers who had stunted children or other nutritional disorders

    Other: laboratory clinical trial study

Interventions

  • Otherlaboratory clinical trial study

    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.

06

What researchers measure

Primary outcomes

  1. calsium, vitamin D, zinc and ferrum serum level

    calsium, vitamin D, zinc and ferrum serum level in the mother's blood

    Time frame: up to 1 day

  2. lipase and amylase enzime pacreatic serum level

    lipase and amylase enzime pacreatic serum level in the mother's blood

    Time frame: up to 1 day

  3. dietary intake per day

    dietary intake per day of mother and child

    Time frame: up to 2 day

07

Study locations

1 site
  • Faculty of Medicine Universitas Sumatera Utara
    Medan, North Sumatra 20155, Indonesia
08

References and documents

Study documents

  • Protocol and informed consent form · Nov 25, 2020

Documents are hosted by the registry — open the source record to download them.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04669106
Lead sponsor
Universitas Sumatera Utara
Responsible party
DINA KEUMALA SARI (Principal Investigator, Universitas Sumatera Utara) — Principal investigator
First posted
Dec 16, 2020
Start date
Sep 2, 2020
Primary completion
Oct 8, 2020
Completion
Nov 10, 2020
Last update
Dec 16, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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