EFFECT OF TWO FORMULATIONS (FIRST FORMULATION: CONTAINING CALCIUM, PHOSPHORUS, VITAMIN-D, AND VITAMIN-B12 IN COMBINATION,SECOND FORMULATION: WITHOUT PHOSPHORUS ) ON THE SERUM LEVELS AFTER 28 DAYS OF TREATMENT IN RATS

                                                         STUDY PROTOCOLS

EFFECT OF TWO FORMULATIONS (CONTAINING CALCIUM, PHOSPHORUS VITAMIN-D, AND VITAMIN-B12 IN COMBINATION) ON THE SERUM LEVELS AFTER 28 DAYS OF TREATMENT IN RATS.

    

1.0  TEST SYSTEM DETAILS:

Species                  : Rattus norvegicus (Rat)

Age                        : 6-7 weeks

Sex                         : Male/Female

No. of animals        : 10 /Group

Total animals         : 50 

2.0   ALLOCATION OF GROUPS:

 

Group No.	Group Description	Treatment administered	Dose Volume and Route
G1	Normal Control	0.5% MC, p.o., b.i.d.	5 ml/kg, p.o.
G2	Treated orally with a low dose of TF1	TF-X1 mg/kg, in 0.5% MC., q.d.
G3	Treated orally with a medium dose of TF1	TF-X2 mg/kg, in 0.5% MC., q.d.
G4	Treated orally with a high dose of TF1	TF-X3 mg/kg, in 0.5% MC., q.d.
G5	Treated orally with a dose of TF2 (without phosphorus)	TF-Y1 mg/kg, in 0.5% MC., q.d.

Abbreviations: MC-Methyl Cellulose, p.o.-per os.; bid: bis in die. X1, X2, X3, and Y1 are the incremental doses of the formulations. The dose range will be from 10 mg/kg to 1000 mg/kg, q.d.

3.0  METHOD:

·       After the completion of quarantine, healthy animals will be selected for the study. Subsequently, they will be randomized based on body weight and allocated into 4, different groups consisting of 10 animals each.

·       Post-randomization, animals will be acclimatized for 5 days in an experimental room earmarked for the experiment.

·     After completion of acclimation, the following treatments will be administered to animals for 28 consecutive days.

Ø Animals of Group G1, designated as normal-control will be administered 0.5% MC, p.o., q.d.

Ø Animals of group G2-G4 will be treated with TF and  G5 will be treated with TF2 orally at different dose levels ranging from 10-1000 mg/kg, q.d.

·       On day 29 animals will be transiently anesthetized with isoflurane and 1 ml of blood will be withdrawn from the retro-orbital sinus. Subsequently, the serum will be separated and the concentrations of Calcium, Phosphorus, Vitamin B_12, and Vitamin D will be estimated.

·       Animals will then be subjected to a two-week wash-off period and can be used for any further study.

 

4.0  PARAMETERS TO BE EVALUATED:

·       Body weight: On day 0 and after that twice a week

·       Serum levels of Calcium, Phosphorus, Vitamin B_12, and Vitamin D

Only to evaluate Vitamin D, please follow the details below video:

                        

                         

Reference:

1. Vitamin D Fact Sheet for Health Professionals

END OF DOCUMENTS

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