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| Name | Class |
|---|---|
| Quzhou Maternal and Child Health Care Hospital | UNKNOWN |
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Inositol is a type of food additives, which plays an important role in insulin signal pathway and is related to insulin sensitivity. Our randomized, double-centered, placebo-controlled study is planned to recruit 360 pregnant women who is in high risk for gestational diabetes. They will be assumed randomly 1 g of D-chiro inositol per day or placebo from 12-16th gestational weeks until Oral Glucose Tolerance Test (OGTT) at 24-28th gestational weeks. Perinatal outcomes about delivery time, neonatal weight will be registered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D-chiro inositol | Active Comparator | 500 mg twice a day |
|
| Placebo | Placebo Comparator | 500 mg twice a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D-chiro inositol | Dietary Supplement | Active group receives inositol 1 gram per day as well as health guidance about diet and exercise. From recruitment until OGTT. |
|
| Measure | Description | Time Frame |
|---|---|---|
| the incidence of gestational diabetes | The number of cases and incidence of gestational diabetes according to OGTT | 24-28th weeks gestation |
| Measure | Description | Time Frame |
|---|---|---|
| the perinatal outcomes-1 | the incidence of macrosomia (macrosomia refers to a newborn weighs more than 4 kg) | Delivery |
| the perinatal outcomes-2 | weight gain during pregnancy (kg) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xinning Chen | Hangzhou | Zhejiang | 310000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39803251 | Background | Chen X, Du Z, Zhang Z, Chen D. D-Chiro Inositol Supplementation and the Occurrence of Gestational Diabetes: A Randomized Controlled Trial in China. Food Sci Nutr. 2024 Dec 5;13(1):e4601. doi: 10.1002/fsn3.4601. eCollection 2025 Jan. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 4, 2021 | Mar 4, 2021 | Prot_000.pdf |
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The random number table is compiled by the investigator who is specially responsible for grouping and saved. The investigator packaged and coded drugs according to random number table, and recorded. The packaged and numbered drugs are stored in the enrollment office.
When the participants meet the inclusion criteria by care providers (doctors), the enrollment office generates a random number for each subject. The participants received the package of drugs according to their random number, and the random number was recorded in the record book.
If there are adverse events or the subjects request to withdraw from the trial, the investigator should uncover the blind.
| Placebo | Dietary Supplement | Placebo (similar appearance but not containing myo-inositol) 1 gram per day before meals. Similar health guidance about diet and exercise. From recruitment until OGTT. |
|
| Delivery |
| the perinatal outcomes-3 | the Caesarean-section incidence (%) | Delivery |