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Completed

NCT Number: NCT03310307

Vitamin D3 Treatment and Homocysteine Concentrations Among Overweight Reproductive Women

100 overweight reproductive vitamin D deficient women were divided into two groups; vitamin D (n = 50) and placebo (n = 50). Vitamin D group received treatment dose of 50,000 IU of vitamin D3 per week for 2 consecutive months and placebo group received placebo tablets similar in size, shape and color to vitamin D3 for 2 months also. Total homocysteine concentrations were measured before intervention (basal), on 30 days (one month) and on 60 days (2 months) of intervention. Changes in means of homocysteine concentrations for placebo and vitamin D group over time showed significant difference on 30 and 60 days of intervention. Mean comparisons of homocysteine concentrations and standard error of the means before and after intervention showed statistical significant decrease in homocysteine concentrations among vitamin D group.

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Key information

Conditions

Homocystinaemia Avitaminosis Body Weight Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vitamin D Deficiency

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

King Abdullah University Hospital

Irbid, Jordan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Overweight (BMI between 25-29.99 kg/m2)
  • Had 25(OH)D < 20 ng/mL
  • Had normal vitamin B-12 and folic acid levels
  • Not diagnosed with any chronic diseases
  • Agreed to participat in the study

Exclusion criteria

  • age < 18 or > 49 years
  • BMI > 30 kg/m2 or < 25 kg/m2
  • 25 (OH)D level > 20 ng/ml
  • tHcy levels greater than 100 µmol/L
  • Abnormal vitamin B-12 or folic acid levels
  • Chronic diseases
  • Pregnant or lactating

Treatment and study plan

Vit D

Drug

50,000 IU

Other names: Biodal

Placebo

Other

Primary outcomes

  1. 25(OH)D3

    Time frame: 2 months

    vitamin D in serum

Secondary outcomes

  1. Homocysteine

    Time frame: 2 months

    serum total homocysteine

Sponsors and collaborators

Lead sponsor

Al-Balqa Applied University

Other

Collaborators

  • Jordan University of Science and Technology

Registry information

Official study title

Vitamin D3 Treatment Decreases Serum Total Homocysteine Concentrations of Overweight Reproductive Women: Randomized Placebo Controlled Clinical Trail

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Oct 16, 2017
Registry last updated
Oct 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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