The efficacy of vitamin D supplementation in infants on bone mineral content: A double blind randomized controlled trial.
Phase 3
Withdrawn
- Conditions
- Improving bone healthMusculoskeletal - OsteoporosisPublic Health - Other public health
- Registration Number
- ACTRN12613000732785
- Lead Sponsor
- niversity of Tasmania
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- All
- Target Recruitment
- 324
Inclusion Criteria
1. Healthy singleton term (>=37 weeks) babies under <1 months of age;
2. Being fully breastfed;
3. 25(OH)D cord blood level 25 - 74 nmol/L;
4. Having a mother who is willing and capable of giving the baby 2 drops of liquid treatment each day;
5. Having a mother who has sufficient English and cognitive ability to understand the study requirements.
Exclusion Criteria
1. Known complications at birth (low birth weight (<2500 g); admission to neonatal intensive care or special care nursery);
2. Infant conditions that interfere with the vitamin D metabolism (cholestatic liver disease, chronic renal insufficiency).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Whole body bone mineral content (BMC), using dual-energy X-ray absorptiometry (DEXA). [Age 2 and age 4 years]
- Secondary Outcome Measures
Name Time Method whole body Bone Mineral Density (BMD), using dual-energy X-ray absorptiometry (DEXA). [At age 2 and 4 years]