The VALIDATE-D Study

NCT01635062 | Completed Results DMC

• 1 other identifier: 2012P000905
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate whether vitamin D receptor agonist therapy lowers renin-angiotensin system activity.

Conditions

Type 2 Diabetes; Obesity

Outcome Measures

Primary Outcomes (1)

• The Change in Circulating RAS Activity After Calcitriol/Placebo Therapy

  The below results represent the change in Plasma Renin Activity.

  baseline and 2 weeks following calcitriol/placebo therapy

Secondary Outcomes (2)

• Change in Renal Plasma Flow After Calcitriol/Placebo Therapy

  baseline and 3 weeks following calcitriol/placebo therapy

• Change in Urine Protein After Calcitriol/Placebo Therapy

  baseline and 3 weeks following calcitriol/placebo therapy

Study Arms (2)

calcitriol

EXPERIMENTAL

Subjects will receive calcitriol (titrated up to 0.75 mcg daily) for 3 weeks.

Drug: Calcitriol

placebo

PLACEBO COMPARATOR

Subjects will receive placebo for 3 weeks.

Drug: Placebo

Interventions

Calcitriol DRUG

Subjects will receive calcitriol (up to 0.75 mcg daily) for 3 weeks.

Also known as: 1,25-dihydroxyvitamin D3

calcitriol

Placebo DRUG

Subjects will receive placebo for 3 weeks.

placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type-Two Diabetes (treated with diet alone, with oral hypoglycemic agents, or with a single injection of basal insulin daily)
• Normal blood pressure, or Mild (Stage 1) Hypertension that is either untreated, or adequately treated with a single anti-hypertensive drug.
• Age \>18 years and \<70 years
• Estimated GFR \> 60ml/min
• Normal laboratory values for: Complete blood count, sodium, potassium, glucose, liver enzymes, urinalysis
• Electrocardiogram without any signs of prior infarction, ventricular conduction abnormality, or supraventricular arrhythmia.

You may not qualify if:

• Chronic Kidney Disease or eGFR\<60
• History of nephrolithiasis (kidney stones)
• Multiple (more than one) insulin injections daily (since insulin can alter the RAS)
• Poorly controlled type 2 diabetes (That may require more aggressive therapy) as defined by an HbA1c\>8.5%
• Type 1 diabetes
• Stage 2 or Stage 3 hypertension or the use of more than 1 antihypertensive drug
• Chronic inflammatory conditions (such as inflammatory bowel disease or arthritis) that are treated with prescribed doses of NSAIDs by a physician.
• The use of prescribed doses of potassium supplements.
• History of liver failure
• History of parathyroid or granulomatous disorders
• History of heart failure, cerebrovascular disease or coronary heart disease
• History of known microvascular complications of diabetes (including retinopathy, neuropathy, nephropathy)
• Illness requiring overnight hospitalization in the past 6 months
• Active tobacco or recreational drug use
• Pregnancy or current breast feeding

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Brown JM, Secinaro K, Williams JS, Vaidya A. Evaluating hormonal mechanisms of vitamin D receptor agonist therapy in diabetic kidney disease: the VALIDATE-D study. BMC Endocr Disord. 2013 Aug 23;13:33. doi: 10.1186/1472-6823-13-33.

  PMID: 23971740 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Interventions

Calcitriol

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dihydroxycholecalciferols; Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Limitations and Caveats

This was a small physiological study, not a treatment study or a typical Phase 1-4 study. The objective was to investigate the mechanistic link between vitamin D receptor agonist therapy and the renin-angiotensin system.

Results Point of Contact

• Title: Dr. Anand Vaidya (Asst Professor of Medicine)
• Organization: Brigham and Women's Hospital

avaidya1@partners.org

6175258285

Study Officials

• Anand Vaidya, MD, MMSc

  Brigham and Women's Hospital, Harvard Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine, Harvard Medical School

Study Record Dates

• First Submitted: July 2, 2012
• First Posted: July 6, 2012
• Study Start: September 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 11, 2017
• Results First Posted: April 11, 2017

Record last verified: 2017-02

Locations

US (1)