---
title: Supplementation With Vitamin D Improves Leptin Resistance
nct_id: NCT00907270
overall_status: UNKNOWN
phase: NA
sponsor: Mexican National Institute of Public Health
study_type: INTERVENTIONAL
primary_condition: Overweight
countries: Mexico
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00907270.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00907270"
ct_last_update_post_date: 2009-05-22
last_seen_at: "2026-05-12T06:18:56.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Supplementation With Vitamin D Improves Leptin Resistance

**Official Title:** Effect of Vitamin D Supplementation on Leptin Resistance, Hunger, Body Weight and Resting Energy Expenditure in Obese Women.

**NCT ID:** [NCT00907270](https://clinicaltrials.gov/study/NCT00907270)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 50
- **Lead Sponsor:** Mexican National Institute of Public Health
- **Conditions:** Overweight, Obesity
- **Start Date:** 2009-09
- **Completion Date:** 2010-05
- **CT.gov Last Update:** 2009-05-22

## Brief Summary

Participants will be randomly assigned in one of two groups. Group A: oral supplementation with 4,000 IU of vitamin D (cholecalciferol). Group B: oral supplementation with 400 IU of vitamin D (cholecalciferol). Both treatments will be consumed daily for 6 months.

Outcomes will be evaluated at baseline, three and six months. Variables related to leptin resistance will be evaluated.

The main hypothesis is that vitamin D will diminish leptin resistance in overweight and obese women. If the hypothesis is confirmed, women will show a reduction in the Resting energy expenditure: serum Leptin ratio (REE: Leptin ratio), as well as a reduction of hunger, body weight, body and abdominal fat and an increase in resting energy expenditure.

## Detailed Description

Study subjects will get dietary advice and physical activity counseling. At the end of the study, participants with suboptimal vitamin D levels (\<80 nmol/L 25-OH-D) will receive treatment to normalize their vitamin D status.

Variables related to leptin resistance like resting metabolic expenditure, hunger, body weight and human body fat will be assessed. Outcomes will include, glucose, insulin, C-reactive protein, inflammatory interleukins (IL-6 \& TNF-α) and non-inflammatory interleukins (IL-10 \& TGF-β-1).

## Eligibility

- **Minimum age:** 45 Years
- **Maximum age:** 65 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* BMI: 25-29.9
* Serum vitamin D levels: 20-80 nmol/L (25-OH-D)

Exclusion Criteria:

* Liver disease
* Kidney disease
* Diabetes mellitus
* Malignity
* Any kind of hormonal disorder
* Medication that modify hunger/satiety answer and those medications that alter -the glucose/insulin metabolism
* Subjects with diet treatment to lose weight
```

## Arms

- **Cholecalciferol: 400 IU/day** (ACTIVE_COMPARATOR) — Control: (n=50) Each subject will be evaluated after supplementation during six months with Vitamin D (Cholecalciferol: 400 IU/day)
- **Cholecalciferol 4000 IU/day** (EXPERIMENTAL) — Experimental: (n=50) Each subject will be evaluated after supplementation during six months with Vitamin D

## Interventions

- **Cholecalciferol** (DIETARY_SUPPLEMENT) — Cholecalciferol: 4,000 IU/day and 400 IU/day

## Primary Outcomes

- **Evaluation of leptin resistance: (resting energy expenditure: leptin ratio) before and after (3 and 6 months) supplementation with vitamin D3 (cholecalciferol) 4,000 or 400 IU/day.** _(time frame: basal, third and sixth month)_

## Secondary Outcomes

- **Effect of vitamin D supplementation (25-OH-D): hunger, body weight, energy intake, resting energy expenditure, and body fat, improvement on low intensity chronic inflammation, SOCS-3 expression and JAK2/STAT3 signal.** _(time frame: Basal, third and sixth month)_

## Locations (1)

- National Institute of Social Insurance, Cuernavaca, Morelos, Mexico

## Recent Field Changes (last 30 days)

- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.national institute of social insurance|cuernavaca|morelos|mexico` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00907270.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00907270*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*