A study to check the safety of a tablet that contains Calcium Aspartate, Magnesium Hydroxide, and Vitamin D3, given to people who have low levels of calcium and vitamin D.

A Non-Randomized, Single Arm, Open Label, Multicentric Post Marketing Study to evaluate safety profile of FDC of Calcium Aspartate 1120 mg plus Magnesium Hydroxide 180 mg plus Vitamin D3 1000 IU film coated tablets in the treatment of Calcium and Vitamin D deficiency - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2025/07/091843

Enrollment

200

Registered

2025-07-28

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

Health Condition 1: M199- Osteoarthritis, unspecified site

Interventions

Intervention1: FDC of Calcium Aspartate 1120 mg + Magnesium Hydroxide 180 mg + Vitamin D3 1000 IU film coated tablet.: To be administered orally once daily, during or right after a meal for 08 Weeks C

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult patients age 18 years and above. 2. Patients those who are already administering this FDC before screening and willing to provide written informed consent form to participate in the study. 3. Patients must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits. 4. Female patients of childbearing potential must have a negative serum pregnancy report and should follow abstinence or use contraceptive methods with a failure rate of less than 1 percent. 5. Patient is eligible for or currently receiving treatment with calcium and vitamin D supplement.

Exclusion criteria

Exclusion criteria: 1. Hypersensitivity to Calcium and Vitamin D and other components of the study drugs. 2. History of severe allergic reactions or drug intolerance. 3. Other significant diseases, at the discretion of the investigator. 4. For non-pregnant Patients: lactating women, or women intending to become pregnant during the study. 5. Has a history of known fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency. 6. Has a disease and or condition resulting in hypercalcaemia and or hypercalciuria and for which the study drugs are contraindicated e.g. Zollinger-Ellison syndrome, nephrolithiasis 7. Patients immediately require any surgical interventions for their bone and joint disease. 8. Patients taking or require Hormone therapy. 9. Patients taking steroidal therapy. 10. Abuse of alcohol or drugs. 11. Hepatic and Renal impairment.

Design outcomes

Primary

Measure	Time frame
To evaluate the safety of patients. Safety assessments will include recording of AE and well-being.Timepoint: Baseline, Day 28 (Week 4), Day 56 (Week 8)	—

Secondary

Measure	Time frame
Timepoint: ;NILTimepoint: NIL	—

Countries

India

Contacts

Public ContactKalpana Sharma

Zyfis Lifesciences Private Limited

dimple.shah@zyfis.in8866662183

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026