Vitamin D and Its Affect on Growth Rates and Bone Mineral Density Until Age 5 (VitD)
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|ClinicalTrials.gov Identifier: NCT01419821|
Recruitment Status : Unknown
Verified August 2011 by Meir Medical Center.
Recruitment status was: Not yet recruiting
First Posted : August 18, 2011
Last Update Posted : February 22, 2013
|Condition or disease||Intervention/treatment||Phase|
|Vitamin D Deficiency||Drug: Vitamin D Other: Placebo (for Vitamin D)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Supplemental Vitamin D Administered to One Year Old Vitamin D Deficient Infants Until Age 3 and Its Affect on Growth Rates and Bone Mineral Density Until Age 5|
|Study Start Date :||September 2013|
|Estimated Primary Completion Date :||September 2014|
|Estimated Study Completion Date :||September 2016|
Active Comparator: Vit D supplementation
Group 2-Infants with 25(OH)D below 15ng/ml receiving continued vitamin D supplementation of 800IU (4gtt/d) for one year.
Drug: Vitamin D
800IU (4gtt/d) once a day for 2 years once a day.
Other Name: TipTipot Vitamin D 200IU/gtt
Placebo Comparator: Placebo group
Group 3- Infants with 25(OH)D below 15ng/ml those receiving the placebo.
Other: Placebo (for Vitamin D)
4gtt/d for the placebo for two years.
No Intervention: Normal group
Group 1- infants with 25(OH)D above 15ng/ml (normal levels) will receive no intervention.
- Height at the age of 3 years [ Time Frame: 3 years after the recruitment begins ]
- Bone densitometry by ultrasound [ Time Frame: 3 years after recruitment begins ]
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): NCT01419821
|Contact: Avigdor Hevroni, MD||972508573982||Avigdor@hadassah.org.il|
|Clalit Health services||Not yet recruiting|
|Beitar Elit, Israel|
|Contact: Clalit 972-2-588-7000|
|Principal Investigator:||Avigdor Hevroni, MD||Hadassah Medical Center|