Evaluation Of Efficacy Of Nanoparticle Vitamin D In Patients With Vitamin D deficiency

Evaluation Of Efficacy Of a Nanoparticle based Vitamin D Formulation In Correction Of Vitamin D Levels In Patients With Documented Deficiency Or Insufficiency Of Vitamin D.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/09/007282

Enrollment

Registered

2016-09-19

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Patients With Documented Deficiency Or Insufficiency Of Vitamin D

Interventions

Intervention1: Nanoparticle based Vitamin D: 60000 InternationalUnit Vitamin D Intervention2: ARACHITOL NANO: Cholecalciferol IP 60000 IU Intervention3: NIL: NIL Intervention4: Nanoparticle based Vita

Eligibility

Inclusion criteria

Inclusion criteria: Adult male or female patients aged 18 to 65 years of age Patients with documented deficiency or insufficiency of vitamin D less than 30 ng per ml Participants should have the ability to understand the requirements of the study Participants willing to abide by the study restrictions and return for the required assessments

Exclusion criteria

Exclusion criteria: Patients less than 18 years of age Patients with uncontrolled diabetes mellitus Pregnant and lactating women Patients with known hypersensitivity to Vitamin D supplement Patients on medications interfering with Vitamin D metabolism Patients with history of malabsorption kidney stones hypoparathyroidism or growth hormone deficiency

Design outcomes

Primary

Measure	Time frame
To evaluate the efficacy of a nanoparticle based vitamin D formulation in correcting the Vitamin D levels after a weekly therapy for 8 weeksTimepoint: 8weeks	—

Secondary

Measure	Time frame
Profile of patients with Vitamin D deficiency and pattern of repletion.Patients global assessment of efficacy on a 5point scale of Excellent Good Moderate Poor and Worst response will be assessed by the patients at the end of therapy.Physician global assessment of efficacy on a 5point scale of Excellent Good Moderate Poor and Worst response will be assessed by the patients at the end of therapyTimepoint: 8weeks	—

Measure

Time frame

Profile of patients with Vitamin D deficiency and pattern of repletion.Patients global assessment of efficacy on a 5point scale of Excellent Good Moderate Poor and Worst response will be assessed by the patients at the end of therapy.Physician global assessment of efficacy on a 5point scale of Excellent Good Moderate Poor and Worst response will be assessed by the patients at the end of therapyTimepoint: 8weeks

—

Countries

India

Contacts

Public ContactDr Kishore Manek

LC MANEKS NURSING HOME And POLYCLINIC

drkishore58@gmail.com25225404

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026