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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Pregnant Women

Treatments: Dietary Supplement: Normal selenium; Dietary Supplement: Weak iron; Dietary Supplement: Weak selenium; Dietary Supplement: Normal iron

Study type: Interventional

Funder types: Other

Identifiers

NCT03651934

hs-1646

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 4 patient groups

Normal iron

Experimental group

Treatment:

Dietary Supplement: Weak iron

Dietary Supplement: Normal iron

Weak iron

Experimental group

Treatment:

Dietary Supplement: Weak iron

Dietary Supplement: Normal iron

Normal selenium

Experimental group

Treatment:

Dietary Supplement: Weak selenium

Dietary Supplement: Normal selenium

Weak selenium

Experimental group

Treatment:

Dietary Supplement: Weak selenium

Dietary Supplement: Normal selenium