NCT04669106

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 2, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2020

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 26, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 16, 2020

Completed
Last Updated

December 16, 2020

Status Verified

December 1, 2020

Enrollment Period

1 month

First QC Date

November 26, 2020

Last Update Submit

December 10, 2020

Conditions

Keywords

nutritional deficiencymacronutrientmineralenzymestunting

Outcome Measures

Primary Outcomes (3)

  • calsium, vitamin D, zinc and ferrum serum level

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

    up to 1 day

  • lipase and amylase enzime pacreatic serum level

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

    up to 1 day

  • dietary intake per day

    dietary intake per day of mother and child

    up to 2 day

Study Arms (2)

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

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.

Healthy groupStunting group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • mothers who had healthy children

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Universitas Sumatera Utara

Medan, North Sumatra, 20155, Indonesia

Location

MeSH Terms

Conditions

MalnutritionCalcinosisGrowth Disorders

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesCalcium Metabolism DisordersMetabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 26, 2020

First Posted

December 16, 2020

Study Start

September 2, 2020

Primary Completion

October 8, 2020

Study Completion

November 10, 2020

Last Updated

December 16, 2020

Record last verified: 2020-12

Locations