Improved Outcomes Associated With Inositol Dietary Supplementation in Women With Gestational Diabetes Mellitus (inositol)
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ClinicalTrials.gov Identifier: NCT01342874 |
Recruitment Status
:
Completed
First Posted
: April 27, 2011
Last Update Posted
: February 9, 2012
|
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Condition or disease | Intervention/treatment |
---|---|
Gestational Diabetes Mellitus | Dietary Supplement: Inositol |
Study Type : | Observational |
Actual Enrollment : | 30 participants |
Observational Model: | Case Control |
Time Perspective: | Prospective |
Official Title: | Improved Maternal and Fetal Outcomes Associated With Inositol Dietary Supplementation in Women With Early Gestational Diabetes Mellitus |
Study Start Date : | August 2010 |
Actual Primary Completion Date : | April 2011 |
Actual Study Completion Date : | August 2011 |

Group/Cohort | Intervention/treatment |
---|---|
Inositol group
Inositol dietary exposure 4000 mg/day
|
Dietary Supplement: Inositol
inositol exposure in early GDM
|
Control group
folic acid 400 mcg/day
|
- Insulin therapy in early diagnosis of GDM [ Time Frame: 6 months ]Inositol supplementation and diet with/without insulin therapy in early GDM
- altered OGTT [ Time Frame: 6 months ]OGTT altered at 24-28 wks in inositol and control group
- delivery and neonatal outcomes [ Time Frame: 6 months ]prevention of maternal and fetal adverse outcomes deriving from GDM (LGA fetuses, poly-hydramnios, C-section rate, gestational age at delivery, birthweight, birth injuries)

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- singleton pregnant women
- random fasting glucose above 92 mg%
Exclusion Criteria:
- BMI >30
- random fasting glucose above 126 mg%

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01342874
Italy | |
University of Chieti | |
Chieti, CH, Italy, 66100 |
Principal Investigator: | Claudio Celentano, MD | ObGyn Dept |
Publications:
Responsible Party: | Claudio Celentano, MD, G. d'Annunzio University |
ClinicalTrials.gov Identifier: | NCT01342874 History of Changes |
Other Study ID Numbers: |
INOS001 |
First Posted: | April 27, 2011 Key Record Dates |
Last Update Posted: | February 9, 2012 |
Last Verified: | April 2011 |
Keywords provided by Claudio Celentano, G. d'Annunzio University:
inositol gestational diabetes mellitus obstetric adverse outcomes |
Additional relevant MeSH terms:
Diabetes Mellitus Diabetes, Gestational Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Pregnancy Complications |
Inositol Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs |