Harmonized Micronutrient Project
A New Strategy to Analyze Gene-Nutrient Interaction in Children and Adolescents
1 other identifier
interventional
146
1 country
1
Brief Summary
The purpose of this trial is to better define how individuals with different genetic make-ups will require different interventions to improve their methylation potential and nutrient status.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 26, 2013
CompletedFirst Posted
Study publicly available on registry
April 4, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedAugust 5, 2014
August 1, 2014
1.3 years
March 26, 2013
August 4, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
SAM/SAH ratio
Change from baseline in the correlation between the SAM/SAH ratio in erythrocytes, dietary intakes and, polymorphisms in genes associated with micronutrients
baseline and after 6 weeks of product intake
Secondary Outcomes (2)
SNP arrays, proteomics, metabolomics, micronutrient levels
baseline, after 6 weeks of product intake and after 6 weeks of follow up
SAM/SAH ratio
after 6 weeks product intake and after 6 weeks of follow up
Study Arms (1)
micronutrient supplementation
EXPERIMENTALAll the enrolled subjects will recieve orally, onca a day, during school days a chocolate bar including vitamins and minerals. The micronitrient supplementation will be consumed over 6 weeks, 5 days/week.
Interventions
Eligibility Criteria
You may qualify if:
- Children or adolescents 9 to 13 years of age.
- Clinically stable.
- Normal weight, overweight and obese.
You may not qualify if:
- Disease diagnosis.
- At least one episode of axillary temperature \>37°C over the prior 15 days.
- Three or more episodes of liquid or semi-liquid stools over the prior 24 hours.
- Supplementation with vitamins and/or minerals.
- On a supervised diet for reducing weight or any other type of diet restriction.
- Currently participating or having participated in another clinical study during the last 4 weeks prior to the beginning of this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Campus Universitário USP, Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Ribeirão Preto, São Paulo, 14-049-900, Brazil
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jacqueline Pontes Monteiro, Profa. Dra.
Campus Universitário USP, Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2013
First Posted
April 4, 2013
Study Start
March 1, 2013
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
August 5, 2014
Record last verified: 2014-08