Effect of combined iron, zinc, and calcium supplementation on iron, zinc, and calcium status in adolescents
- Conditions
- Micronutrient deficienciesNutritional, Metabolic, EndocrineNutritional deficiency
- Registration Number
- ISRCTN11852796
- Lead Sponsor
- niversity of Chile (Chile)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 160
Current inclusion criteria as of 18/01/2017:
1. Male or female
2. 16 - 18 years old
3. In good health
4. Sexual maturity rating of Tanner stage 5
Previous inclusion criteria:
1. Male or female
2. 16 - 17 years old
3. In good health
4. Sexual maturity rating of Tanner stage 5
1. Use of vitamin supplements containing iron, zinc, calcium, vitamin D during the last 6 months prior the beginning of the trial
2. Known intolerance/allergy to iron, zinc, and calcium supplements
3. Smoking and alcohol abuse or dependence
4. Morbidity (excepting anemia defined as hemoglobin < 120 g/L)
5. Participation in previous studies particularly involving the administration of micronutrient supplements
6. Pregnant or planning a pregnancy during the study period
7. Breastfeeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Bone mineralization (as an outcome of Ca supplementation)<br> 2. Iron nutrition status measured by:<br> 2.1. Hemoglobin<br> 2.2. Mean corpuscular volume<br> 2.3. Zn protoporphyrin<br> 2.4. Serum ferritin<br> 2.5. Total iron binding capacity<br> 2.6. Serum Iron<br> 2.7. Hepcidin<br> 2.8. Transferrin receptor<br> 2.9. Transferrin saturation<br> 2.10. Total body iron<br> 3. Zinc nutrition status measured by circulating Zn levels<br>
- Secondary Outcome Measures
Name Time Method ot provided at time of registration