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

NCT ID: NCT03651934

Last Updated: 2018-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2020-06-01

Brief Summary

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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

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Conditions

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Pregnant Women

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Normal iron

Group Type EXPERIMENTAL

Normal iron

Intervention Type DIETARY_SUPPLEMENT

The intervention was divided into two stages, the first stage lasted for 4 weeks, and the dosage used was the dietary nutrient recommendation amount, namely the dietary recommendation amount standard for early pregnancy (iron 20mg/d), and the middle stage of pregnancy (iron 24mg/d). The second stage lasts for 4 weeks. For subjects in iron deficiency, the maximum tolerable amount (iron 42mg/d) is used for intervention. For those with good nutritional status, the dietary recommendation amount is maintained.

Weak iron

Intervention Type DIETARY_SUPPLEMENT

The intervention was divided into two stages, the first stage lasted for 4 weeks, and the dosage used was the dietary nutrient recommendation amount, namely the dietary recommendation amount standard for early pregnancy (iron 20mg/d), and the middle stage of pregnancy (iron 24mg/d). The second stage lasts for 4 weeks. For subjects in iron deficiency, the maximum tolerable amount (iron 42mg/d) is used for intervention. For those with good nutritional status, the dietary recommendation amount is maintained.

Weak iron

Group Type EXPERIMENTAL

Normal iron

Intervention Type DIETARY_SUPPLEMENT

The intervention was divided into two stages, the first stage lasted for 4 weeks, and the dosage used was the dietary nutrient recommendation amount, namely the dietary recommendation amount standard for early pregnancy (iron 20mg/d), and the middle stage of pregnancy (iron 24mg/d). The second stage lasts for 4 weeks. For subjects in iron deficiency, the maximum tolerable amount (iron 42mg/d) is used for intervention. For those with good nutritional status, the dietary recommendation amount is maintained.

Weak iron

Intervention Type DIETARY_SUPPLEMENT

The intervention was divided into two stages, the first stage lasted for 4 weeks, and the dosage used was the dietary nutrient recommendation amount, namely the dietary recommendation amount standard for early pregnancy (iron 20mg/d), and the middle stage of pregnancy (iron 24mg/d). The second stage lasts for 4 weeks. For subjects in iron deficiency, the maximum tolerable amount (iron 42mg/d) is used for intervention. For those with good nutritional status, the dietary recommendation amount is maintained.

Normal selenium

Group Type EXPERIMENTAL

Normal selenium

Intervention Type DIETARY_SUPPLEMENT

The intervention was divided into two stages, the first stage lasted for 4 weeks, and the dosage used was the dietary nutrient recommendation amount, namely the dietary recommendation amount standard for early pregnancy (selenium 60ug/d), and the middle stage of pregnancy (selenium 65ug/d). The second stage lasts for 4 weeks. For subjects in selenium deficiency, the maximum tolerable amount (selenium 400ug/d) is used for intervention. For those with good nutritional status, the dietary recommendation amount is maintained.

Weak selenium

Intervention Type DIETARY_SUPPLEMENT

The intervention was divided into two stages, the first stage lasted for 4 weeks, and the dosage used was the dietary nutrient recommendation amount, namely the dietary recommendation amount standard for early pregnancy (selenium 60ug/d), and the middle stage of pregnancy (selenium 65ug/d). The second stage lasts for 4 weeks. For subjects in selenium deficiency, the maximum tolerable amount (selenium 400ug/d) is used for intervention. For those with good nutritional status, the dietary recommendation amount is maintained.

Weak selenium

Group Type EXPERIMENTAL

Normal selenium

Intervention Type DIETARY_SUPPLEMENT

The intervention was divided into two stages, the first stage lasted for 4 weeks, and the dosage used was the dietary nutrient recommendation amount, namely the dietary recommendation amount standard for early pregnancy (selenium 60ug/d), and the middle stage of pregnancy (selenium 65ug/d). The second stage lasts for 4 weeks. For subjects in selenium deficiency, the maximum tolerable amount (selenium 400ug/d) is used for intervention. For those with good nutritional status, the dietary recommendation amount is maintained.

Weak selenium

Intervention Type DIETARY_SUPPLEMENT

The intervention was divided into two stages, the first stage lasted for 4 weeks, and the dosage used was the dietary nutrient recommendation amount, namely the dietary recommendation amount standard for early pregnancy (selenium 60ug/d), and the middle stage of pregnancy (selenium 65ug/d). The second stage lasts for 4 weeks. For subjects in selenium deficiency, the maximum tolerable amount (selenium 400ug/d) is used for intervention. For those with good nutritional status, the dietary recommendation amount is maintained.

Interventions

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Normal iron

The intervention was divided into two stages, the first stage lasted for 4 weeks, and the dosage used was the dietary nutrient recommendation amount, namely the dietary recommendation amount standard for early pregnancy (iron 20mg/d), and the middle stage of pregnancy (iron 24mg/d). The second stage lasts for 4 weeks. For subjects in iron deficiency, the maximum tolerable amount (iron 42mg/d) is used for intervention. For those with good nutritional status, the dietary recommendation amount is maintained.

Intervention Type DIETARY_SUPPLEMENT

Weak iron

The intervention was divided into two stages, the first stage lasted for 4 weeks, and the dosage used was the dietary nutrient recommendation amount, namely the dietary recommendation amount standard for early pregnancy (iron 20mg/d), and the middle stage of pregnancy (iron 24mg/d). The second stage lasts for 4 weeks. For subjects in iron deficiency, the maximum tolerable amount (iron 42mg/d) is used for intervention. For those with good nutritional status, the dietary recommendation amount is maintained.

Intervention Type DIETARY_SUPPLEMENT

Normal selenium

The intervention was divided into two stages, the first stage lasted for 4 weeks, and the dosage used was the dietary nutrient recommendation amount, namely the dietary recommendation amount standard for early pregnancy (selenium 60ug/d), and the middle stage of pregnancy (selenium 65ug/d). The second stage lasts for 4 weeks. For subjects in selenium deficiency, the maximum tolerable amount (selenium 400ug/d) is used for intervention. For those with good nutritional status, the dietary recommendation amount is maintained.

Intervention Type DIETARY_SUPPLEMENT

Weak selenium

The intervention was divided into two stages, the first stage lasted for 4 weeks, and the dosage used was the dietary nutrient recommendation amount, namely the dietary recommendation amount standard for early pregnancy (selenium 60ug/d), and the middle stage of pregnancy (selenium 65ug/d). The second stage lasts for 4 weeks. For subjects in selenium deficiency, the maximum tolerable amount (selenium 400ug/d) is used for intervention. For those with good nutritional status, the dietary recommendation amount is maintained.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Liuyanping

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Yanpin Liu, bachelor

Role: CONTACT

+861069159088

Yixuan Hou, master

Role: CONTACT

+8618810112590

References

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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.

Reference Type DERIVED
PMID: 34455263 (View on PubMed)

Other Identifiers

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hs-1646

Identifier Type: -

Identifier Source: org_study_id

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