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Effect of Vitamin D on Metabolic Profile in Overweight or Obese Women

T

Tehran University of Medical Sciences

Status and phase

Completed
Phase 3

Conditions

Overweight
Obesity

Treatments

Dietary Supplement: Placebo
Dietary Supplement: vitamin D

Study type

Interventional

Funder types

Other

Identifiers

NCT01344161
IRCT138809092709N2

Details and patient eligibility

About

The investigators investigated the effect of vitamin D3 supplementation on metabolic profile (anthropometric measures, blood pressure Lipids, lipoproteins and glycemic indices) in overweight or obese women.

Full description

Vitamin D deficiency is a worldwide health problem and is determined as a risk factor in Cardiometabolic disorders including Cardiovascular disease, Metabolic syndrome, and type 2 diabetes mellitus. The investigators investigated the effect of vitamin D3 supplementation on metabolic profile in overweight or obese women.

A double blind randomized clinical trial was conducted in 77 premenopause overweight or obese women. Participants were classified into two groups : vitamin D supplementation [1000 IU/day as cholecalciferol tablets (n=39)] or placebo (n=38). Vein blood samples were taken after at least 12 hours overnight fasting. Selected anthropometric measures, blood pressure Lipids, lipoproteins and glycemic indices were measured at baseline and after 12 weeks. Body fat mass was determined using BIA. Also the investigators assessed dietary intake using 24 hours food recall and semi-quantitative food frequency and physical activity using IPAQ questionnaires.

The investigators conducted the study between October 2009 and March 2010 at the Medical school, Tehran, Iran. Recruitment began in October 2009 via advertisements and was terminated in October 2009. The investigators excluded patients with a history of Cardiovascular disease, Liver disease, Gastrointestinal disease, Kidney disease, diabetes mellitus, and Osteoporosis. Moreover, pregnancy, lactation, vegetarianism, and intake of dietary supplements were the exclusion criteria.

Enrollment

85 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Female
  • 18-50 years old
  • Premenopause
  • BMI ≥25

Exclusion criteria

  • Cardiovascular disease
  • Liver disease
  • Gastrointestinal disease
  • Kidney disease
  • Diabetes mellitus
  • Osteoporosis
  • Pregnancy
  • Lactation

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

85 participants in 2 patient groups, including a placebo group

Lactose
Placebo Comparator group
Treatment:
Dietary Supplement: Placebo
Vitamin D
Experimental group
Treatment:
Dietary Supplement: vitamin D

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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