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OpenTrials
Completed

NCT Number: NCT01631292

Vitamin D Supplementation in Obesity and Weight Loss (3DD Study)

In this study, we will provide supplemental vitamin D in postmenopausal overweight/obese women, and hypothesize that it will not affect areal BMD, but will alter bone compartments (trabecular and cortical bone). In addition, higher vitamin D intake will increase serum 25OHD and suppress serum PTH and bone turnover during weight reduction. Secondary outcomes include the influence of vitamin D and weight loss on markers of insulin resistance and on cognitive tests of attention, learning, and memory.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

50 year–72 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rutgers University- Thompson Hall

New Brunswick, New Jersey, 08901, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Body mass index of 25-40 kg/m2
  • Postmenopausal
  • Age 50-72 years

Exclusion criteria

  • Women who are taking any medication known to influence Calcium or bone metabolism,
  • Evidence of diseases known to influence Calcium metabolism (i.e. metabolic bone disease)
  • hyperparathyroidism
  • untreated thyroid disease
  • significant immune disease
  • hepatic disease
  • renal disease or a kidney stone in the last 5 years
  • significant cardiac disease
  • active malignancy or cancer therapy within the past year

Treatment and study plan

600 IU Vitamin D3

Dietary Supplement

Once daily

2000 IU Vitamin D3

Dietary Supplement

Once daily

4000 IU Vitamin D3

Dietary Supplement

Once daily

Primary outcomes

  1. Bone mineral density (BMD)

    Time frame: 1 year

    BMD

  2. Bone quality

    Time frame: 1 year

    thickness (mm)

Secondary outcomes

  1. Bone turnover markers

    Time frame: Baseline, 6 months, 12 months

    osteocalcin (others include PINP and CTX)

  2. Glycemic indices

    Time frame: Baseline, 6 months and 12 months

    glucose and insulin

  3. Cognition and biochemical markers

    Time frame: One year

    Cognitive measures and serum biochemical markers

  4. cholesterol absorption

    Time frame: baseline and one year

    Serum levels

  5. serum vitamin D

    Time frame: Baseline, 6 months and 12 months

    25(OH)D

  6. Bone regulating hormones

    Time frame: Baseline, 6 months and 12 months

    PTH

Sponsors and collaborators

Lead sponsor

Rutgers University

Other

Registry information

Official study title

A Pilot Dose Response Study to Vitamin D in Obesity and Weight Loss: Effect on Bone

Important dates

Study start
2010
Primary completion
2015
Study completion
2019
First posted
Jun 29, 2012
Registry last updated
Nov 22, 2023

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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