How Chewable Calcium Tablets Can Help Reduce Tingling and Numbness During Platelet Donations

Effectiveness of the various formulation of oral chewable calcium supplementation as prophylaxis measure to prevent citrate effect in plateletpheresis donors: A Randomized Control Trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/084665

Enrollment

326

Registered

2025-04-13

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-28

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

Conditions

None listed

Interventions

Intervention1: Experimental group: Two oral chewable tablet of Calcium phosphate 2.1 gm (elemental calcium 500 mg): Drug: Calcium phosphate

Dose: Calcium phosphate 2.1 gm having elemental calcium 500 mg

Route: Oral Chewable tablets

Frequency: Two doses

Total Duration of Intervention: Before 30 minutes and at 20 minutes of start of plateletpheresis procedure Control Intervention1: Comparator group: One oral chewable tablet of Calcium phosphate 2.1 gm

Route: Oral Chewable tablet

Frequency: Single dose

Total Duration of Intervention: Before 30 minutes of start of plateletpheresis procedure

Eligibility

Inclusion criteria

Inclusion criteria: Donor fit for single donor platelet collection as per the Drugs and Cosmetic Act. Good health, mentally and physically fit Weight: at least 50 kg Blood Pressure: 100-140mm Hg systolic, 60-90 mm Hg diastolic Pulse: 60-100, regular Hemoglobin: More than or equal to 12.5 g/dl The site of phlebotomy should be free from any skin disease

Exclusion criteria

Exclusion criteria: High-risk behaviour Any minor non-specific and major illnesses Veins are not good for phlebotomy on both arms A platelet count of less than or equal to 150X103/ L In the case of female donors, pregnant, menstruating, and lactating mother On Salicylates (aspirin) and other NSAIDs Previously Positive for any transfusion-transmitted infections like HIV, Hepatitis B or C, or Syphilis.

Design outcomes

Primary

Measure	Time frame
Tingling sensation, perioral numbness, paraesthesia s of extremities, Nausea, shivering, vomiting, abdominal pain, cramps, tetany, any other adverse events related to hypocalcemiaTimepoint: Start of procedure till presence of adverse events during procedure and follow-up till 48 hours after completion of the procedure. The adverse event after procedure till 48 hours will be confirmed telephonically.	—

Measure

Time frame

Tingling sensation, perioral numbness, paraesthesia s of extremities, Nausea, shivering, vomiting, abdominal pain, cramps, tetany, any other adverse events related to hypocalcemiaTimepoint: Start of procedure till presence of adverse events during procedure and follow-up till 48 hours after completion of the procedure. The adverse event after procedure till 48 hours will be confirmed telephonically.

—

Secondary

Measure	Time frame
NILTimepoint: NIL	—

Countries

India

Contacts

Public ContactDr Satya Prakash

AIIMS Bhubaneswar

tranmed_prakash@aiimsbhubaneswar.edu.in8872533400

Outcome results