Verification of Correlation Between Genetic Testing of Nutritional Metabolism and Clinical Biochemical Indicators

Not Applicable

• Conditions: Pregnant Women
• Interventions: Dietary Supplement: Normal iron; Dietary Supplement: Normal selenium; Dietary Supplement: Weak iron; Dietary Supplement: Weak selenium

• Registration Number: NCT03651934
• Lead Sponsor: Peking Union Medical College Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-08
• Study First Submitted: 2018-08-06
• Study First Submitted QC: 2018-08-27
• Last Update Submitted: 2018-08-27
• Study First Posted: 2018-08-29
• Last Update Posted: 2018-08-29
• Study Start: 2018-10-01
• Primary Completion: 2019-09-10
• Study Completion: 2020-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 600

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal iron	Normal iron	-
Weak iron	Weak iron	-
Normal selenium	Weak selenium	-
Normal iron	Weak iron	-
Weak iron	Normal iron	-
Normal selenium	Normal selenium	-
Weak selenium	Normal selenium	-
Weak selenium	Weak selenium	-

Primary Outcome Measures

Name	Time	Method
Correlation between the results of nutritional evaluation of iron-related genes and iron levels in vivo	lasted for 4 weeks	The correlation between the nutrition evaluation results of iron gene monitoring and the levels of iron in vivo
Correlation between gestational diabetes-related gene monitoring results and glycosylated hemoglobin，fasting blood glucose, fasting insulin levels in vivo	lasted for 4 weeks	The correlation between the nutrition evaluation results of gestational diabetes-related gene monitoring and the levels of glycosylated hemoglobin，fasting blood glucose, fasting insulin in vivo
Correlation between the results of nutritional evaluation of selenium-related genes and selenium levels in vivo	lasted for 4 weeks	The correlation between the nutrition evaluation results of selenium gene monitoring and the levels of selenium in vivo
Correlation between the results of nutritional evaluation of vitamin B6-related genes and vitamin B6 levels in vivo	lasted for 4 weeks	The correlation between the nutrition evaluation results of vitamin B6 gene monitoring and the levels of vitamin B6 in vivo
Correlation between the results of nutritional evaluation of vitamin B12-related genes and vitamin B12 levels in vivo	lasted for 4 weeks	The correlation between the nutrition evaluation results of vitamin B12 gene monitoring and the levels of vitamin B12 in vivo
Correlation between the results of nutritional evaluation of vitamin D-related genes and vitamin D levels in vivo	lasted for 4 weeks	The correlation between the nutrition evaluation results of vitamin D gene monitoring and the levels of vitamin D in vivo
Correlation between the results of nutritional evaluation of pantothenic acid-related genes and pantothenic acid levels in vivo	lasted for 4 weeks	The correlation between the nutrition evaluation results of pantothenic acid gene monitoring and the levels of pantothenic acid in vivo
Correlation between gestational hypertension-related gene monitoring results and homocysteine, serum folic acid and RBC Folate levels in vivo	lasted for 4 weeks	TThe correlation between the nutrition evaluation results of gestational hypertension-related gene monitoring and the levels of homocysteine, serum folic acid and RBC Folate in vivo
Correlation between hyperlipidemia-related gene monitoring results and the level of plasma lipid in vivo.	lasted for 4 weeks	The correlation between the nutrition evaluation results of hyperlipidemia-related gene monitoring and the levels of plasma lipid in vivo
nutritional status	lasted for 4 weeks	The nutritional status of selenium was compared between the normal selenium and week selenium group; The nutritional status of iron was compared between the normal iron and the weak group. Meanwhile, compare the selenium and iron nutritional status of the four groups before and after the intervention.