Comparison of the effects of vitamin D versus placebo on the components of metabolic syndrome in children and adolescents aged 10-16 years

Comparison of the effects of vitamin D versus placebo on the components of metabolic syndrome in children and adolescents aged 10-16

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201110271434N5

Enrollment

Registered

2012-09-24

Start date

2011-03-21

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

metabolic syndrome. Other disorders of lipoprotein metabolism

Interventions

Intervention 1: group case : vitamin D supplement , 3 pearls 50000IU (150000IU) at the beginning and 3 pearls (150000IU) 4 weeks later . group Control : Placebo , 3 pearl at the beginning and 3 pea

Treatment - Drugs

group case : vitamin D supplement , 3 pearls 50000IU (150000IU) at the beginning and 3 pearls (150000IU) 4 weeks later . group Control : Placebo , 3 pearl at the beginning and 3 pearls 4 weeks lat

For group control : given Placebo (which made in Zahravi-pharma company and they are empty pearl) 3 pearls given at the beginning and 3 pearls after 4 weeks. After 12 weeks from the starting step, i

Eligibility

Sex/Gender

All

Age

10 Years to 16 Years

Inclusion criteria

Inclusion criteria: Input Criteria: Children and adolescents (10-16 years old) , afflicted by metabolic syndrome and not afflicted by underlying chronic disease who do not consume any particular medicine ; Output Criteria: An individual or their family’s inclination to keeping commitment with the plan (scheme)

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Serum level of vitamin D. Timepoint: before treatment and 3 months following end od treatment. Method of measurement: ng/ml - specific kits.;Systolic blood pressure. Timepoint: before treatment and 3 months following end od treatment. Method of measurement: Mercury Sphygmomanometerwith the accuracy of 1 mmgh.;Diastolic blood pressure. Timepoint: before treatment and 3 months following end od treatment. Method of measurement: Mercury Sphygmomanometerwith the accuracy of 1 mmgh.;High-density Lipoprotein. Timepoint: before treatment and 3 months following end od treatment. Method of measurement: mg/dL - enzymatic - photometric.;Low-density lipoprotein. Timepoint: before treatment and 3 months following end od treatment. Method of measurement: mg/dL - enzymatic - photometric.;Triglyceride. Timepoint: before treatment and 3 months following end od treatment. Method of measurement: mg/dL - enzymatic - photometric.;Insuline. Timepoint: before treatment and 3 months following end od treatment. Method of measurement: Elisa.;Plasma Glucose. Timepoint: before treatment and 3 months following end od treatment. Method of measurement: mg/dL - Glucose oxidase.;Insuline resistance. Timepoint: before treatment and 3 months following end od treatment. Method of measurement: HOMA-IR.	—

Measure

Time frame

Serum level of vitamin D. Timepoint: before treatment and 3 months following end od treatment. Method of measurement: ng/ml - specific kits.;Systolic blood pressure. Timepoint: before treatment and 3 months following end od treatment. Method of measurement: Mercury Sphygmomanometerwith the accuracy of 1 mmgh.;Diastolic blood pressure. Timepoint: before treatment and 3 months following end od treatment. Method of measurement: Mercury Sphygmomanometerwith the accuracy of 1 mmgh.;High-density Lipoprotein. Timepoint: before treatment and 3 months following end od treatment. Method of measurement: mg/dL - enzymatic - photometric.;Low-density lipoprotein. Timepoint: before treatment and 3 months following end od treatment. Method of measurement: mg/dL - enzymatic - photometric.;Triglyceride. Timepoint: before treatment and 3 months following end od treatment. Method of measurement: mg/dL - enzymatic - photometric.;Insuline. Timepoint: before treatment and 3 months following end od treatment. Method of measurement: Elisa.;Plasma Glucose. Timepoint: before treatment and 3 months following end od treatment. Method of measurement: mg/dL - Glucose oxidase.;Insuline resistance. Timepoint: before treatment and 3 months following end od treatment. Method of measurement: HOMA-IR.

—

Secondary

Measure	Time frame
Body mass index. Timepoint: before treatment and 3 months following end of treatment. Method of measurement: weight / (height)2 - kg/m2.;Waist circumference. Timepoint: before treatment and 3 months following end of treatment. Method of measurement: cm - tapeline.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShadi Salek Ardetani

Isfahan University of Medical Sciences

salek.shadi@gmail.com+98 31 1668 5555

Outcome results

None listed

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