EVALUATION OF THE EFFECT OF ONE NOVEL NUTRACEUTICAL FORMULATION ON THE SERUM LEVEL OF 25 (OH) VITAMIN –D IN RATS FED A VITAMIN D-DEFICIENT DIET.

EVALUATION OF THE EFFECT OF ONE NOVEL NUTRACEUTICAL FORMULATION ON THE SERUM LEVEL OF 25 (OH) VITAMIN –D IN RATS FED A VITAMIN D-DEFICIENT DIET

1.0 TEST SYSTEM DETAILS:

Species : Rattus norvegicus (Rats)

Strain: Sprague Dawley or Wistar

Age : 3 weeks

Sex : Male and Female

No. of animals : 12/Group (6 Male + 6 Female)

Total animals : 84

 

2.0 TEST ARTICLES DETAILS

HF1: Vitamin D supplement derived from lichen.

3.0 VEHICLE DETAILS

The test articles will be formulated by utilizing 0.5% methylcellulose as the vehicle.

4.0 ALLOCATION OF GROUPS:

Group No.	Group Description	Disease Induction procedure	Treatment administered	Dose Volume and Route
G1	Normal Control	Normal Laboratory Diet × 8 weeks	0.5% MC, p.o., q.d.	5 ml/kg, p.o.
G2	Disease Control	All animals will be given a customized Vitamin D-deficient diet from the third week of their age × 8 weeks	0.5% MC, p.o., q.d.
G3	Reference Control		D3 Must 2K 200 IU/kg, p.o., q.d.
G4	Treated with a low dose of HF1		HF1: 60 IU/kg, q.d.
G5	Treated with a High dose of HF1		HF1: 120 IU/kg, q.d.
G6	Treated with a High dose of HF1		HF1: 200 IU/kg, q.d.
G7	Treated with a High dose of HF1		HF1: 600 IU/kg, q.d.

5.0 METHOD:

· Healthy animals will be selected for the study immediately after completion of the weaning period, randomized based on body weight, and will be assigned to 7 groups consisting of 12 (6 male + 6 female) animals each.

· Animals of Group G1 will be designated as normal-control and administered 0.5% MC, p.o., b.i.d.

· Disease control animals (assigned to group G2) will receive 0.5% MC, p.o., b.i.d.

· Animals of group G3 will be treated with reference drug D3 Must 2K at the dose of 200 IU/kg, p.o., b.i.d.

· Animals of group G4-G7 will be treated with HF-1, at different incremental dose levels as outlined in the above table.

· The normal control group (G1) will be fed a Normal Laboratory Diet, whereas animals allocated to groups G2 – G7 will be fed a Vitamin D Deficient Customized (or normocalcemic-vitamin D-deficient diet) diet for the next six weeks.

· Immediately after, the completion of week six animals of group G2-G7 will be randomized based on 25 (OH) vitamin –D levels.

· Compound, reference standard, and vehicle administration will be initiated from day 43 for the next two weeks (till day 56), after confirmation of Vitamin D Deficiency in groups G2-G7.

· On day 0, before the initiation of Vitamin D-deficient diet, blood parameters will be determined for the baseline data. Vitamin D deficient diet will be given for 6 weeks and Vitamin D level will be evaluated every two weeks. Animals will be treated with formulations/Reference drugs/vehicles for two weeks after confirmation. Subsequently, after week eight on day 57, all animals will be sacrificed under an overdose of thiopentone anesthesia. After suitable anesthesia but before the animal dies, blood will be collected from the retro-orbital plexus for the estimation of Vitamin D parameters. Immediately after the animal dies, the liver and kidneys will be weighed and stored at -80°C for the ensuing biochemical and molecular evaluations.

6.0 PARAMETERS TO BE EVALUATED:

· Body weight: Twice a week.

· Determination of 25 (OH) Vitamin –D level in blood serum.

· Determination of 25 (OH) Vitamin-D levels in liver and kidney

7.0 REFERENCE(S):

1. Abulmeaty MM, Almajwal AM, Alam I, Razak S, ElSadek MF, Aljuraiban GS, Hussein KS, Malash AM. Relationship of vitamin D-deficient diet and irisin, and their impact on energy homeostasis in rats. Frontiers in physiology. 2020 Jan 31;11:25.

2. Stavenuiter AW, Arcidiacono MV, Ferrantelli E, Keuning ED, Vila Cuenca M, Ter Wee PM, Beelen RH, Vervloet MG, Dusso AS. A novel rat model of vitamin D deficiency: safe and rapid induction of vitamin D and calcitriol deficiency without hyperparathyroidism. BioMed research international. 2015 Feb 28;2015.

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