A study to assess the change of bone mineral in response to increased dietary calcium intake in children.
- Registration Number
- CTRI/2023/05/052693
- Lead Sponsor
- The New York Academy of Sciences.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Healthy children between 6 to 10 years old. Vitamin D 25OHD ( > 20ng/mL). Non-anaemic Hb >11.5.0 g/dL. Z score >- 2SD. Not taking any food supplements/fortified drinks. Not planning to move out during the study duration.
Age: <6 and >10 years Severe anemia (Hb <8g/dl) Severely malnourished children with weight for height Z score < -3SD Any food allergy or food intolerance Any metabolic, gastrointestinal kidney or chronic diseases such as diabetes, hepatitis, hypertension, cancer, or cardiovascular diseases (according to the participant’s statement) Continuous/long-term use of medication during the whole study Consumption of mineral and vitamin supplements within 2 weeks before the start of the study Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months Earlier participation in any clinical study within the last 30 days A participant who cannot be expected to comply with the study protocol (e.g., not available on certain study appointments) Likely to move out of the study area within the period of the study intervention. Difficulties with blood samplinG.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the change in urinary calcium as a reliable biomarker for calcium status/bone mineralization in children in response to increased dietary calcium intake. <br/ ><br>Timepoint: Weeks 1,4,8,12
- Secondary Outcome Measures
Name Time Method ILTimepoint: NI