The Effect of Vitamin D Supplementation During Caloric Restriction on Intestinal Calcium Absorption

NCT00472654 | Completed DMC

• 3 other identifiers: AG0083R01AG012161AG012161
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn how the amount of vitamin D supplementation influences intestinal fractional calcium absorption (a measure of the amount of calcium absorbed).

Conditions

Weight Loss; Vitamin D or Placebo

Keywords

bone mass; calcium absorption; bone quality; fracture risk

Outcome Measures

Primary Outcomes (1)

• Changes in Calcium absorption

  6 weeks

Secondary Outcomes (1)

• Changes in serum and urine bone markers, hormones, glucose, proteins and genes

  6 weeks

Study Arms (4)

WL

PLACEBO COMPARATOR

Behavioral: Weight Loss

WL + D

EXPERIMENTAL

Behavioral: Weight Loss; Dietary Supplement: Vitamin D 2500 IU

WM

PLACEBO COMPARATOR

Behavioral: Weight Maintenance

WM + D

ACTIVE COMPARATOR

Dietary Supplement: Vitamin D 2500 IU; Behavioral: Weight Maintenance

Interventions

Weight Loss BEHAVIORAL

Diet for weight loss for 6 weeks; all weight loss participants will attend 6 weekly counseling sessions (about 50 minutes per session)

WL; WL + D

Vitamin D 2500 IU DIETARY_SUPPLEMENT

Daily Vitamin D 2500 IU supplement for 6 weeks

WL + D; WM + D

Weight Maintenance BEHAVIORAL

Diet for weight maintenance for 6 weeks

WM; WM + D

Eligibility Criteria

• Age: 50 Years - 72 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal women who are more than 2 years since last menses
• Obese or overweight
• Must live in the geographic vicinity of Rutgers University

You may not qualify if:

• Currently on any medication known to influence calcium or bone metabolism, including HRT, or with evidence of diseases known to influence calcium metabolism (i.e. metabolic bone disease, hyperparathyroidism, untreated thyroid disease, significant immune, hepatic, or renal disease, significant cardiac disease \[i.e., heart attack or stroke in the past 6 months., abnormal EKG\], active malignancy or cancer therapy within the past year)
• History of kidney stones
• Weight gain or weight loss (5% of body wt) within 3 months prior to recruitment
• Participation in other investigational studies during the study period
• Travel for longer than 2 consecutive weeks during the study period
• Usually have a very high or low intake of calcium (more than 1500 or less than 500 mg per day)

Sponsors & Collaborators

• Rutgers University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Rutgers University

New Brunswick, New Jersey, 08901, United States

Location

Related Publications (6)

• Shapses SA, Riedt CS. Bone, body weight, and weight reduction: what are the concerns? J Nutr. 2006 Jun;136(6):1453-6. doi: 10.1093/jn/136.6.1453.

  PMID: 16702302 BACKGROUND

• Riedt CS, Cifuentes M, Stahl T, Chowdhury HA, Schlussel Y, Shapses SA. Overweight postmenopausal women lose bone with moderate weight reduction and 1 g/day calcium intake. J Bone Miner Res. 2005 Mar;20(3):455-63. doi: 10.1359/JBMR.041132. Epub 2004 Nov 29.

  PMID: 15746990 BACKGROUND

• Cifuentes M, Riedt CS, Brolin RE, Field MP, Sherrell RM, Shapses SA. Weight loss and calcium intake influence calcium absorption in overweight postmenopausal women. Am J Clin Nutr. 2004 Jul;80(1):123-30. doi: 10.1093/ajcn/80.1.123.

  PMID: 15213038 BACKGROUND

• Goode LR, Brolin RE, Chowdhury HA, Shapses SA. Bone and gastric bypass surgery: effects of dietary calcium and vitamin D. Obes Res. 2004 Jan;12(1):40-7. doi: 10.1038/oby.2004.7.

  PMID: 14742841 BACKGROUND

• Shapses SA, Sukumar D, Schneider SH, Schlussel Y, Brolin RE, Taich L. Hormonal and dietary influences on true fractional calcium absorption in women: role of obesity. Osteoporos Int. 2012 Nov;23(11):2607-14. doi: 10.1007/s00198-012-1901-5. Epub 2012 Jan 27.

  PMID: 22282301 BACKGROUND

• Shapses SA, Sukumar D, Schneider SH, Schlussel Y, Sherrell RM, Field MP, Ambia-Sobhan H. Vitamin D supplementation and calcium absorption during caloric restriction: a randomized double-blind trial. Am J Clin Nutr. 2013 Mar;97(3):637-45. doi: 10.3945/ajcn.112.044909. Epub 2013 Jan 30.

  PMID: 23364004 RESULT

MeSH Terms

Conditions

Weight Loss

Interventions

Vitamin D; Body Weight Maintenance

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Body Weight; Body Size; Growth; Growth and Development; Physiological Phenomena

Study Officials

• Sue Shapses, PhD

  Rutgers University, Nutritional Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 10, 2007
• First Posted: May 14, 2007
• Study Start: March 1, 2007
• Primary Completion: May 1, 2010
• Study Completion: March 1, 2011
• Last Updated: March 28, 2023

Record last verified: 2022-01

Locations

US (1)