Pregnant WomenNCT03651934
Verification of Correlation Between Genetic Testing of Nutritional Metabolism and Clinical Biochemical Indicators
A study testing Normal iron, Weak iron and Normal selenium in people with Pregnant Women, run by Peking Union Medical College Hospital.
Trial 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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pregnant Women
- What is being tested?
- Normal iron, Weak iron and Normal selenium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2018to 1 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Pregnant Women
- Being tested
- Normal iron, Weak iron, Normal selenium, Weak selenium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal ironDietary 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 ironDietary 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 seleniumDietary 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 seleniumDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Normal iron | Experimental | Not described Receives: Dietary Supplement: Normal iron; Dietary Supplement: Weak iron |
| Weak iron | Experimental | Not described Receives: Dietary Supplement: Normal iron; Dietary Supplement: Weak iron |
| Normal selenium | Experimental | Not described Receives: Dietary Supplement: Normal selenium; Dietary Supplement: Weak selenium |
| Weak selenium | Experimental | Not described Receives: Dietary Supplement: Normal selenium; Dietary Supplement: Weak selenium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the results of nutritional evaluation of selenium-related genes and selenium levels in vivo
The correlation between the nutrition evaluation results of selenium gene monitoring and the levels of selenium in vivo
Measured: lasted for 4 weeks
Correlation between the results of nutritional evaluation of iron-related genes and iron levels in vivo
The correlation between the nutrition evaluation results of iron gene monitoring and the levels of iron in vivo
Measured: lasted for 4 weeks
Correlation between the results of nutritional evaluation of vitamin B6-related genes and vitamin B6 levels in vivo
The correlation between the nutrition evaluation results of vitamin B6 gene monitoring and the levels of vitamin B6 in vivo
Measured: lasted for 4 weeks
Correlation between the results of nutritional evaluation of vitamin B12-related genes and vitamin B12 levels in vivo
The correlation between the nutrition evaluation results of vitamin B12 gene monitoring and the levels of vitamin B12 in vivo
Measured: lasted for 4 weeks
Correlation between the results of nutritional evaluation of vitamin D-related genes and vitamin D levels in vivo
The correlation between the nutrition evaluation results of vitamin D gene monitoring and the levels of vitamin D in vivo
Measured: lasted for 4 weeks
Correlation between the results of nutritional evaluation of pantothenic acid-related genes and pantothenic acid levels in vivo
The correlation between the nutrition evaluation results of pantothenic acid gene monitoring and the levels of pantothenic acid in vivo
Measured: lasted for 4 weeks
Correlation between gestational diabetes-related gene monitoring results and glycosylated hemoglobin，fasting blood glucose, fasting insulin levels in vivo
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
Measured: lasted for 4 weeks
Correlation between gestational hypertension-related gene monitoring results and homocysteine, serum folic acid and RBC Folate levels in vivo
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
Measured: lasted for 4 weeks
Correlation between hyperlipidemia-related gene monitoring results and the level of plasma lipid in vivo.
The correlation between the nutrition evaluation results of hyperlipidemia-related gene monitoring and the levels of plasma lipid in vivo
Measured: lasted for 4 weeks
nutritional status
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.
Measured: lasted for 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start1 Oct 2018 (estimated)
- Primary completion10 Sep 2019 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnant WomenStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liuyanping, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03651934
- Sponsor's protocol ID
- hs-1646
- Status last verified
- Aug 2018
- First submitted
- 6 Aug 2018
- Last updated
- 29 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34455263
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verification of Correlation Between Genetic Testing of Nutritional Metabolism and Clinical Biochemical Indicators
- ClinicalTrials.gov ID
- NCT03651934
- Acronym / sponsor ID
- hs-1646
- Conditions
- Pregnant Women
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- 10 Sep 2019 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 29 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal iron | Experimental | Dietary Supplement: Normal iron, Dietary Supplement: Weak iron |
| Weak iron | Experimental | Dietary Supplement: Normal iron, Dietary Supplement: Weak iron |
| Normal selenium | Experimental | Dietary Supplement: Normal selenium, Dietary Supplement: Weak selenium |
| Weak selenium | Experimental | Dietary Supplement: Normal selenium, Dietary Supplement: Weak selenium |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal ironThe 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 | Normal iron, Weak iron |
| Weak ironThe 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 | Normal iron, Weak iron |
| Normal seleniumThe 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 | Normal selenium, Weak selenium |
| Weak seleniumThe 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 | Normal selenium, Weak selenium |
Primary outcome
Correlation between the results of nutritional evaluation of selenium-related genes and selenium levels in vivo
Time frame: 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 iron-related genes and iron levels in vivo
Time frame: lasted for 4 weeks
The correlation between the nutrition evaluation results of iron gene monitoring and the levels of iron in vivo
Correlation between the results of nutritional evaluation of vitamin B6-related genes and vitamin B6 levels in vivo
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 diabetes-related gene monitoring results and glycosylated hemoglobin，fasting blood glucose, fasting insulin levels in vivo
Time frame: 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 gestational hypertension-related gene monitoring results and homocysteine, serum folic acid and RBC Folate levels in vivo
Time frame: 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.
Time frame: 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
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
- Derived from this study: PubMed 34455263Zhao 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Normal iron, Weak iron and Normal selenium in people with Pregnant Women, run by Peking Union Medical College Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanpin Liu, bachelor (+861069159088, liuyp1227@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between the results of nutritional evaluation of selenium-related genes and selenium levels in vivo (time frame: lasted for 4 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03651934, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2018; AzTrials last refreshed its copy on 7 Nov 2026.