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A study to assess the change of bone mineral in response to increased dietary calcium intake in children.

Bone mineral changes in response to increasing dietary calcium intake in children, a study to assess the natural variability of urinary isotopes of calcium.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/05/052693
Enrollment
50
Registered
2023-05-16
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Cookie: Dose: 500 mg of Calcium Carbonate Frequency: once a day Route of administration: Oral Duration of intervention:12 weeks Control Intervention1: Cookie: Dose:100 mg of Calcium

Sponsors

The New York Academy of Sciences.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: Age: 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.

Design outcomes

Primary

MeasureTime frame
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. Timepoint: Weeks 1,4,8,12

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactDr Prashanth Thankachan

St.Johns National Academy of Health Sciences

prashanth.t@sjri.res.in91-9886006166

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026