Home
Search
Study Topics
Glossary
|
Study 18 of 18 for search of: | United Arab Emirates |
Previous Study | Return to Search Results | Next Study |
|
|
|
|
|
Sponsors and Collaborators: |
Children's Hospital Medical Center, Cincinnati United Arab Emirates University Thrasher Research Fund |
---|---|
Information provided by: | Children's Hospital Medical Center, Cincinnati |
ClinicalTrials.gov Identifier: | NCT00610688 |
The purpose of this research study is to compare the effects of higher dose vitamin D with commonly recommended dose in pregnant women to see which is better in maintaining normal vitamin D blood levels during pregnancy and in newborn infants.
Condition | Intervention | Phase |
---|---|---|
Vitamin D Deficiency |
Drug: Prenatal Vitamin Drug: Cholecalciferol (Vitamin D3) |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver), Dose Comparison, Parallel Assignment, Efficacy Study |
Official Title: | High Prevalence of Rickets and Subclinical Maternal and Childhood Vitamin D Deficiency in the Middle East: a Randomized Controlled Trial of Prenatal Vitamin D Supplementation to Prevent Vitamin D Deficiency in Mothers and Their Infants |
Estimated Enrollment: | 180 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Placebo Comparator
Arm will receive prenatal vitamin with 400IU of Vitamin D along with a placebo tablet containing 0IU of Vitamin D
|
Drug: Prenatal Vitamin
Once daily, prenatal vitamin containing 400IU of Vitamin D, until delivery
|
2: Experimental
Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 1600IU of Vitamin D
|
Drug: Prenatal Vitamin
Once daily, prenatal vitamin containing 400IU of Vitamin D, until delivery
Drug: Cholecalciferol (Vitamin D3)
Once daily, 1600IU dose of Vitamin D from 12 weeks gestation to delivery
|
3: Experimental
Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 3600IU of Vitamin D
|
Drug: Prenatal Vitamin
Once daily, prenatal vitamin containing 400IU of Vitamin D, until delivery
Drug: Cholecalciferol (Vitamin D3)
Once daily, 3600IU dose of Vitamin D, from 12 weeks until delivery
|
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Hussein F Saadi, MD | +971-3-703-9651 |
United States, Ohio | |
Cincinnati Children's Hospital Medical Center | Active, not recruiting |
Cincinnati, Ohio, United States, 45229 | |
United Arab Emirates, Abu Dhabi | |
United Arab Emirated Unitersity | Recruiting |
Al-Ain, Abu Dhabi, United Arab Emirates | |
Contact: Hussein F Saadi, MD +971-3-703-9651 | |
Principal Investigator: Hussein F Saadi, MD |
Principal Investigator: | Adekunle Dawodu, MBBS | Children's Hospital Medical Center, Cincinnati |
Principal Investigator: | Hussein F Saadi, MD | United Arab Emirates University |
Responsible Party: | Cincinnati Children's Hospital Medical Center ( Adekunle Dawodu, MBBS/Professor of Pediatrics, Director, International Patient Care & Education ) |
Study ID Numbers: | PA 03-103 |
Study First Received: | December 27, 2007 |
Last Updated: | June 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00610688 |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board; United Arab Emirates: General Authority for Health Services for Abu Dhabi |
Vitamin D Deficiency Cholecalciferol Vitamin D Malnutrition Avitaminosis |
Rickets Ergocalciferols Nutrition Disorders Deficiency Diseases |
Growth Substances Vitamins Physiological Effects of Drugs |
Bone Density Conservation Agents Micronutrients Pharmacologic Actions |