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

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03651934
Collaborator
(none)
600
4
20

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Normal iron
  • Dietary Supplement: Weak iron
  • Dietary Supplement: Normal selenium
  • Dietary Supplement: Weak selenium
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
600 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Verification of Correlation Between Genetic Testing of Nutritional Metabolism and Clinical Biochemical Indicators
Anticipated Study Start Date :
Oct 1, 2018
Anticipated Primary Completion Date :
Sep 10, 2019
Anticipated Study Completion Date :
Jun 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Normal iron

Dietary Supplement: 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.

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.

Experimental: Weak iron

Dietary Supplement: 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.

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.

Experimental: Normal selenium

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.

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.

Experimental: Weak selenium

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.

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Peking Union Medical College Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Liuyanping, Clinical Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT03651934
Other Study ID Numbers:
  • hs-1646
First Posted:
Aug 29, 2018
Last Update Posted:
Aug 29, 2018
Last Verified:
Aug 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 29, 2018