Who is sponsoring NCT03193944?

NCT03193944 is sponsored by Alborz Medical University.

What drugs are being tested in NCT03193944?

Interventions in NCT03193944: D-vitin, soft gelatin capsule (vitamin D3,50000 IU), Placebo vitamin D3.

What condition does NCT03193944 study?

NCT03193944 studies Vitamin D Deficiency, Diabetes Mellitus, Hypertension, Lipid Metabolism Disorders, Obesity, Abdominal.

Is NCT03193944 still recruiting?

NCT03193944 is currently completed. Last updated 16 January 2018.

Last reviewed 2018-01-16 · How we verify

NCT03193944

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Vitamin D Supplementation on Metabolic Syndrome Indicators Among Older Adults, Alborz Province, Iran

Completed Phase 2 Last updated 16 January 2018

What this trial tests

Phase 2 trial testing D-vitin, soft gelatin capsule (vitamin D3,50000 IU) in Vitamin D Deficiency in 120 participants. Completed in 10 July 2017.

Timeline

10 February 2017

Primary endpoint
10 May 2017

10 July 2017

Quick facts

Lead sponsor	Alborz Medical University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	120
Start date	10 February 2017
Primary completion	10 May 2017
Estimated completion	10 July 2017
Sites	1 location across Iran

Drugs / interventions tested

D-vitin, soft gelatin capsule (vitamin D3,50000 IU) — full drug profile →
Placebo vitamin D3

Conditions studied

Vitamin D Deficiency — all drugs for Vitamin D Deficiency →
Diabetes Mellitus — all drugs for Diabetes Mellitus →
Hypertension — all drugs for Hypertension →
Lipid Metabolism Disorders — all drugs for Lipid Metabolism Disorders →

Sponsor

Alborz Medical University

Who can join

Adults 60 to 80, any sex, with Vitamin D Deficiency or Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

General objective: To assess the effect of vitamin D supplementation on metabolic syndrome among food insecure and vitamin D deficient older adults in Karaj city, Alborz province in Iran. A two-arm randomised controlled trial (RCT) will be conducted by recruiting participants. Inclusion Criteria: Food insecure, metabolic syndrome; Vitamin D deficiency Exclusion Criteria: those who are already taking any type of vitamin D supplements, Individuals with a history of allergy, Those subjects with serious medical condition such as cancer, heart attack, stroke, and etc., Intervention group: The intervention will start from 10 of May 2017 to 11 of July 2017 for 2 months. The intervention group will receive 50,000 U vitamin D3 per week (equivalent to 1,250 μg) for 8 weeks plus pamphlets and brochures about nutrition and health at the beginning of the study. Control group: The respondents in control group will receive placebo plus brochures and pamphlets related to nutrition and health at the beginning of the study. The data collection process will identify the older adults for both groups; intervention and control. Consent will be obtained from those who are eligible. Anthropometric measurement (height, weight, body mass index, and waist circumference), blood pressure measurement, blood taking and three-day food record will be obtained during baseline from all study respondents in the intervention and control groups. Primary Output: Achieving 25 (OH) D upper than insufficient serum 25(OH) D level \>30 ng/l. Secondary Output: Reduction anthropometry (body mass index (BMI) and waist circumference (WC), Improved Biomarkers indicators (lipid profile, fasting blood fast), improved blood pressure before and after intervention.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Vitamin D Deficiency

Currently open trials in the same condition.

NCT07317830 — Effects of Different Vitamin D3 Formulations in Vitamin D-Deficient Adults · NA · recruiting
NCT07366970 — Is There a Benefit From Addition of Exercise in Diabetic Patients With ED Who Complain Low Vitamin D? · NA · recruiting
NCT07481240 — A Household-Based Dietary Intervention Study of Vitamin D Fortified Bread in Irish Families · NA · recruiting
NCT07006714 — Preoperative Correction of Vitamin D Deficiency in Total Joint Arthroplasty (TJA) · Phase 4 · active not recruiting
NCT07200011 — Effect of Vitamin D on the Clinical and Radiographic of Unsplinted Mandibular Implant Overdentures · active not recruiting

Other Alborz Medical University trials

Trials by the same sponsor.

NCT05070468 — Effect of Dexamethasone on Labor Induction · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03193944 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Alborz Medical University
Last refreshed: 16 January 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03193944.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing