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

This is a non-randomized, single-arm, open-label, multicentric post-marketing study designed to evaluate the safety of a fixed-dose combination (FDC) of Calcium Aspartate 1120 mg, Magnesium Hydroxide 180 mg, and Vitamin D3 1000 IU film-coated tablets in adults with calcium and vitamin D deficiency. A total of 200 patients will be enrolled and administered the study product orally once daily for a duration of eight weeks.

The primary focus of the study is on safety assessment, which includes monitoring of adverse events, evaluation of patient well-being, and recording of any concomitant medications. Adult patients aged 18 years and above who are already using the study FDC and willing to provide informed consent are eligible to participate. Female participants of childbearing potential must have a negative pregnancy test and must agree to use highly effective contraception or maintain abstinence.

Exclusion criteria include hypersensitivity to any components of the study drug, history of severe allergic reactions, relevant medical conditions such as hepatic or renal impairment, hypercalcemia, and conditions like nephrolithiasis or Zollinger-Ellison syndrome. Patients requiring hormone or steroid therapy, those with a history of substance abuse, or those participating in another clinical study will also be excluded.

Subjects may be withdrawn from the study due to serious adverse events, protocol non-compliance, pregnancy, voluntary withdrawal of consent, or at the discretion of the investigator, Ethics Committee, or sponsor. All withdrawal reasons will be recorded, and in the case of serious adverse events, the relevant Ethics Committee and sponsor will be notified within 24 hours.

In conclusion, this FDC offers a well-balanced combination of calcium, magnesium, and vitamin D to support bone health and overall wellness. Its convenient single-tablet format enhances compliance and effectiveness in addressing common nutritional deficiencies.