Clinical trial NCT03651934: Verification of Correlation Between Genetic Testing of Nutritional Metabolism and Clinical Biochemical Indicators
Official title: Verification of Correlation Between Genetic Testing of Nutritional Metabolism and Clinical Biochemical Indicators
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnant Women
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 600
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The research plan is divided into two parts. The first part is the correlation study .It is planned to include women who prepare for pregnancy or in the early stages of pregnancy to carry out the detection of 25 loci SNP of 21 genes of 9 nutrients, to predict the nutritional abnormalities of 9 nutrients, and to determine the nutritional status of 9 nutrients, and then verify the correlation between nutrient metabolism related gene SNP and nutrient nutrition status .The second part selects iron and selenium which are commonly lacking in Chinese women of childbearing age. A intervention study is designed for these two nutrients. According to the SNP grouping of related gene loci, observe the effect of nutrition intervention and explore the nutrition intervention strategies of different SNP individuals.


Eligibility criteria: Inclusion Criteria:

* preparing for pregnancy or early pregnancy women (\< 12w)
* no major surgery, trauma, or important viscera disease
* no long-term medication history
* No serious mental and psychological behavior abnormalities
* resident in Beijing, can accept regular prenatal in Beijing area
* signed informed consent

Exclusion Criteria:

* have taken medications that may affect the metabolism of nutrients, but are unable to provide their ingredients or doses, making it difficult to judge their effects
* From the first three months of this pregnancy to the time of inclusion, taking drugs that interfere with the absorption, metabolism, and utilization of nutrients.
* From the first three months of this pregnancy to the time of inclusion, Pregnant woman took iron, selenium, vitamin B6, vitamin B12, vitamin D preparations, and the dosage was higher than the corresponding physiological standard.

Primary outcomes:
measure: Correlation between the results of nutritional evaluation of selenium-related genes and selenium levels in vivo
timeFrame: lasted for 4 weeks
measure: Correlation between the results of nutritional evaluation of iron-related genes and iron levels in vivo
timeFrame: lasted for 4 weeks
measure: Correlation between the results of nutritional evaluation of vitamin B6-related genes and vitamin B6 levels in vivo
timeFrame: lasted for 4 weeks
measure: Correlation between the results of nutritional evaluation of vitamin B12-related genes and vitamin B12 levels in vivo
timeFrame: lasted for 4 weeks
measure: Correlation between the results of nutritional evaluation of vitamin D-related genes and vitamin D levels in vivo
timeFrame: lasted for 4 weeks
measure: Correlation between the results of nutritional evaluation of pantothenic acid-related genes and pantothenic acid levels in vivo
timeFrame: lasted for 4 weeks
measure: Correlation between gestational diabetes-related gene monitoring results and glycosylated hemoglobin，fasting blood glucose, fasting insulin levels in vivo
timeFrame: lasted for 4 weeks
measure: Correlation between gestational hypertension-related gene monitoring results and homocysteine, serum folic acid and RBC Folate levels in vivo
timeFrame: lasted for 4 weeks
measure: Correlation between hyperlipidemia-related gene monitoring results and the level of plasma lipid in vivo.
timeFrame: lasted for 4 weeks
measure: nutritional status
timeFrame: lasted for 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Zhao R, An Z, Sun Y, Xia L, Qiu L, Yao A, Liu Y, Liu L. Metabolic profiling in early pregnancy and associated factors of folate supplementation: A cross-sectional study. Clin Nutr. 2021 Sep;40(9):5053-5061. doi: 10.1016/j.clnu.2021.01.012. Epub 2021 Jan 23.